Original Article

Efficacy of Teriparatide in Increasing Bone Mineral

Density in Postmenopausal Women with Osteoporosis
An Indian Experience
BK Sethi*, M Chadha**, KD Modi***, KM Prasanna Kumar+, R Mehrotra++,
Usha Sriram+++

Abstract
Background and Objective: Osteoporosis is emerging as a leading cause of substantial morbidity in India,
particularly in postmenopausal women. Teriparatide (recombinant human parathyroid hormone [1-34])
increases bone formation and improves bone microarchitecture, thereby reducing the risk of fractures. This
study was conducted to evaluate the efficacy of teriparatide in increasing bone mineral density (BMD) in
postmenopausal women with osteoporosis.
Material and Methods: A randomised, prospective, multicentre, open-label, controlled study was conducted
on 82 postmenopausal women with established osteoporosis. Patients were randomly divided into control
and teriparatide groups, each group consisting of 41 patients. All the patients were supplemented with
1000 mg of elemental calcium and 500 IU of vitamin D throughout the study period of 180 days. Besides,
teriparatide group patients were administered teriparatide 20 g daily subcutaneously. Lumbar spine, femoral
neck and total hip BMD, bone mineral content (BMC) and bone area were measured by dual energy x-ray
absorptiometry (DXA) at baseline and at the end of 6 months of treatment. Bone biomarkers, such as serum
bone specific alkaline phosphatase (BSAP) and serum osteocalcin (OC), representing bone formation, and
urinary deoxypyridinoline (DPD), representing bone resorption were assessed at baseline, and at 3 and 6
months of treatment.
Results: During the study period, 9 patients (11%) were lost to follow-up - 6 in control group (7.3%) and 3
in teriparatide group (3.7%). There was an excellent compliance to both oral and injectable medication. The
investigational product teriparatide was well tolerated and there were no serious adverse events. In addition,
there were no significant differences between the groups in the incidence of adverse events. The percentage
of increase in lumbar spine BMD, which is the primary endpoint, was significantly (P<0.001) higher in
teriparatide group compared to that in control group (6.58% vs. 1.06%). Further, teriparatide significantly
increased percentage of change in lumbar spine T-score (P<0.001), BMC (P<0.001) and bone area (P<0.028)
compared to control group at 6 months. Administration of teriparatide resulted in a significant percentage
of increase in all the bone biomarkers in teriparatide group compared to control group patients at 3 and 6
months over baseline, thereby showing that there was a significant increase in bone turnover in teriparatide
group of patients.
Conclusion: These results show that teriparatide is an effective and safe drug in increasing the BMD and
therefore, teriparatide provides yet another new therapeutic option for reducing the risk management of
osteoporosis in postmenopausal women (clinicaltrials.gov number, NCT00500409).

*Senior Consultant, Department of Endocrinology, CARE

Hospital, Hyderabad. **Consultant, Department of Endocrinology,
PD Hinduja National Hospital and Medical Research Centre,
Mumbai. ***Consultant, Department of Endocrinology, Medwin
Hospitals, Hyderabad. +Professor and Head of the Department
of Endocrinology & Metabolism, MS Ramaiah Medical College,
Bangalore. ++Senior Consultant, Department of Endocrinology,
Apollo Hospitals, Hyderabad. +++Senior Consultant, Department
of Endocrinology, Apollo Hospitals, Chennai.
Received : 3.2.2008; Accepted : 23.4.2008

418

INTRODUCTION
steoporosis has now been recognised as a major
public health problem associated with substantial
morbidity and socio-economic burden. As a result of
osteoporosis, one in two women and one in five men over
the age of 50, sustain fractures.1 Postmenopausal women,
in particular, are more vulnerable to osteoporosis. After
menopause, due to lack of oestrogen, the rate of bone
turnover increases, resulting in accelerated bone loss.

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JAPI VOL. 56 JUNE 2008

A recent study reports 29% prevalence of osteoporosis

in 30-60 year age group Indian women.2
Majority of currently approved therapies for
osteoporosis act by inhibition of bone resorption and
remodelling. Despite their great value, use of these
anti-resorptive agents generally leads to marginal
increases in BMD from 1-8%, and fracture risk reduction
from 30-50%.3,4 Parathyroid hormone (PTH) analogue,
teriparatide (recombinant human PTH [1-34]), represents
a new class of anabolic therapies for management
of severe osteoporosis both in men and women. 5-6
Teriparatide stimulates bone formation, increases
bone mass, and improves microarchitecture. A large
randomized, placebo-controlled trial of teriparatide
reported dose-related increases in lumbar spine BMD of
9.7-13.7% after a median treatment of 21 months with a
significant reduction in both incident vertebral (65-69%)
and non-vertebral fractures (~53%).7
Ethnicity and race are well known determinants of
skeletal health and bone mineral density. BMD values
in Indian population are approximately 15% lower than
those in Caucasian women.8,9 In addition, fractures are
reported to occur 10 20 years earlier in Indians than in
the western population.10 One of the reasons could be
that majority of Indians have low vitamin D status and
are on low dietary calcium which makes them prone
to bone diseases.11 Keeping these factors in view, the
present study was conducted to evaluate the efficacy
and safety of teriparatide in Indian postmenopausal
women with osteoporosis.

METHODS
Study design
An open-label, multicentre, prospective, randomised,
controlled phase III study was conducted, with the
approval of Drug Controller General of India, at 6
outpatient endocrinology clinical centres in India, from
December 2005 to August 2007. The primary efficacy
endpoint was the percentage of change at the end of 6
months over baseline in bone mineral density (BMD)
at lumber spine (L1-L4) in postmenopausal women
with osteoporosis. The secondary efficacy endpoint
was percentage of change from baseline in biomarkers
of bone formation [serum bone specific alkaline
phosphatase (BSAP) and serum osteocalcin (OC)], and
bone resorption [urinary deoxypyridinoline (DPD)] at
the end of 3 and 6 months. Study protocol was approved
by the Ethics Committees of respective investigational
centres.
Study Participants
Postmenopausal women, at least 3 years past
menopause, were eligible to participate if they were
aged between 45-75 years and had osteoporosis (lumbar
spine or femoral neck or total hip T-score -2.5). Women
were excluded if they had vertebral abnormalities
in L1-L4 that interfered with measurement by dual
JAPI VOL. 56 JUNE 2008

energy X-ray absorptiometry (DXA). Other exclusion

criteria were: women with significant liver disease,
gastrointestinal disease, renal insufficiency (serum
creatinine >2.0 mg/dl) or kidney stones; abnormal
thyroid function (serum TSH normal range 0.5-5.0
IU/ml); vitamin D deficiency (serum 25-OH vitamin
D <20 ng/ml); serum PTH > 65 pg/ml; history of
cancer within last 10 years; women who had used any
medications that were known to affect bone (oestrogen
and oestrogen-related compounds, bisphosphonates,
fluoride, or calcitonin) within the previous 6 months or
currently taking systemic prednisone, inhaled steroids,
anticoagulants and anticonvulsants. Written informed
consent was obtained from all patients before they were
enrolled into the study.
Treatment
Teriparatide used in the study was obtained by
expression of the human PTH gene in Escherichia coli
and was manufactured by Virchow Biotech. During
screening, postmenopausal women, who consented to
participate in the study, were supplemented with 1000
mg of elemental calcium and 500 IU of vitamin D for
45 days. Eligible patients were randomly assigned to
either control group or teriparatide group in the ratio
of 1:1 following the block randomisation list generated
for each of the 6 investigating centres, with block sizes
of 4. Besides 45 days of run-in phase period, all the
patients received elemental calcium and vitamin D
during the entire study period of 180 days; in addition,
patients in teriparatide group received teriparatide 20
g subcutaneously once a day. Compliance with the
treatment was evaluated by tablet count of oral drug
(1000 mg elemental calcium and 500 IU of vitamin D)
and measurement of volume of injectable study material
(teriparatide) returned at each visit.
DXA parameters
T-scores, BMD, bone area and BMC at the lumbar
spine (L1-L4), total hip and femoral neck were measured
by DXA at baseline and at six months, using either
Hologic (n=52) or GE Lunar (n=30) densitometer. Same
instrument at each centre was used for measurement at
baseline and at 6 months.
Biochemical investigations
Blood and urine samples were collected at screening,
baseline, 1, 3 and 6 months for haematological and
biochemical parameters. Samples were stored at -80 0C
till they were analysed centrally. Routine haematology
tests were conducted at the predefined laboratories of
the respective centres. Serum 25-OH vitamin D, serum
PTH and serum TSH were assessed at screening. While
radioimmunoassay was used for vitamin D estimation,
chemiluminescence immunoassay was used for serum
TSH and PTH. In addition serum calcium and creatinine,
urinary calcium and creatinine were monitored at each
visit. Serum bone specific alkaline phosphatase (BSAP),
serum osteocalcin (OC) and urinary deoxypyridinoline

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419

(DPD) were measured with ELISA using Metra

Biosystems, Mountview, CA, USA at baseline, at 3 and
6 months.
Adverse events
Patients were questioned at each visit about any
adverse events, including minor complaints regardless
of association with the study medication.
Statistical Analysis
The primary endpoint for efficacy evaluation was
change in lumbar spine BMD. Difference in lumbar
spine BMD between control and teriparatide treated
groups was reported to be 0.025 g/cm2 with a standard
deviation change of 0.036.12 Based on this, the number
of subjects needed per treatment group was calculated
using following assumptions: 5% level of significance,
80% power for two-sided test assuming 15% attrition
rate. The calculated sample required was 39 patients
in each arm.
The results of all women who received at least one dose
after randomisation were included in the intent-to-treat
analysis. Data on baseline characteristics were analysed
for differences between control and teriparatide treated
groups by using t-test for independent samples. All the
statistical tests were performed at 0.05% (two-sided test)
-level. The primary criterion was percentage of change
in lumbar spine BMD from baseline to 6 months. The
differences in the percentage of change from baseline
to 6 months between control and teriparatide treated
groups in DXA parameters were tested by using nonparametric Wilcoxon - Mann - Whitney U test. The
secondary criterion was percentage of change from
baseline in biomarkers of bone formation and bone
resorption at the end of 3 and 6 months. The differences
in the percentage of change from baseline to 3 and 6
months between control and teriparatide treated groups
in bone biomarkers were tested by using non-parametric
Wilcoxon - Mann - Whitney U test. The differences in
the incidence of adverse events between control and
teriparatide treated groups were tested by using Z-test
for proportions. All tests were performed with the use
of SAS statistical software, version 8 (SAS Institute).

RESULTS
A total of 207 postmenopausal women with
suspected osteoporosis were subjected to DXA screening
at 6 investigational centres. Among them 91 failed in
DXA and the remaining 116 postmenopausal women
with osteoporosis (lumbar spine or total hip or femoral
neck T score <-2.5) were supplemented with elemental
calcium 1000 mg and vitamin D 500 IU daily. After 45
days, they were screened for their eligibility, and 82
women met the eligibility criteria. They were randomly
assigned to either control group (n=41) or teriparatide
group (n=41). Of a total of 82 patients, 73 patients (89%)
completed the trial and only nine patients 6 in control
group and 3 in teriparatide group, were lost to follow-up
420

(Fig. 1). There was no significant difference in number

of patients lost to follow-up between the groups. Both
oral and injectable medications were well tolerated and
as a result, compliance with oral medication averaged
97.3% and 98.1% for the control group and teriparatide
group respectively. Similarly compliance with injectable
medication was 97.4% in teriparatide group.
The baseline characteristics of patients assigned
to two groups are presented in Table 1. At baseline,

Fig. 1 : Enrolment and outcomes

Table 1 : Baseline characteristics of participating patients

Parameter


Age (yr)
Postmenopausal years
Height (cm)
Weight (kg)
BMI (kg/m2)
Lumbar spine T-Score
Lumbar spine BMD (g/cm2)
Lumbar spine bone
area (cm2)
Lumbar spine BMC (g)
Total hip T-Score
Total hip BMD (g/cm2)
Total hip bone area (cm2)
Total hip BMC (g)
Femoral neck T-Score
Femoral neck BMD (g/cm2)
Femoral neck bone area (cm2)
Femoral neck BMC (g)
Serum calcium (mg/dl)
Serum 25-OH vitamin D
(ng/ml)
Serum PTH (pg/ml)
Serum TSH (IU/ml)

Control
Group
( n = 41)

Teriparatide
Group
( n = 41)

63.0 6.3
16.0 7.6
149.9 5.6
56.9 9.7
25.3 3.9
-3.33 0.74
0.71 0.10
44.45 5.54

61.0 6.3
15.7 6.4
149.3 5.6
58.5 10.2
26.2 4.1
-3.40 0.87
0.71 0.13
44.61 4.61

31.62 5.81
-1.88 0.89
0.73 0.10
30.30 3.69
22.10 4.30
-2.34 0.73
0.62 0.09
4.54 0.31
2.83 0.44
9.4 0.5
64.1 32

31.75 7.31
-1.99 0.57
0.71 0.08
29.89 4.94
21.57 4.35
-2.49 0.55
0.62 0.08
4.56 0.40
2.81 0.42
9.4 0.6
63.7 34.3

38.9 16.4
3.1 1.6

34.9 15.9
2.6 1.4

Values are mean SD

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no significant differences between two groups were

observed in demographic characteristics, DXA and
biochemical parameters. Treatment with teriparatide
resulted in a significant (P<0.001) increase in lumbar
spine BMD at 6 months over baseline, which was the
primary endpoint. The percentage of increase in lumbar
spine BMD was 6-fold higher in teriparatide treated
patients compared to that of control group (6.58 Vs.
1.06). Besides, there were also significant increases in
lumbar spine T-score, bone area and BMC. In contrast
to lumbar spine, teriparatide group did not result in
significant changes in T-score, BMD, bone area and BMC
at total hip and femoral neck (Table 2).
Teriparatide treatment produced a significant
increase in all measured biochemical markers of bone
formation (serum BSAP and serum OC) and bone
resorption (urinary DPD) both at 3 and 6 months over
baseline (Fig. 2).

Safety profile in the two study groups was similar,

adverse events were reported in 9 patients both in
control and teriparatide groups (Table 3). Though 11
adverse events were reported in control group and
18 in teriparatide group, these differences were not
statistically significant. In addition, the incidence of
specific adverse events was similar between the control
and teriparatide groups. There were also no serious
adverse events in any of the patients of control and
teriparatide groups.

DISCUSSION
Osteoporosis is a major public health problem that
will become more widespread as the population ages.
Osteoporosis, being a risk factor for fracture, accounts for
high morbidity and mortality, especially in the elderly.
Postmenopausal women are highly susceptible to
osteoporosis and its associated complications. In recent
years, therefore, greater attention has been focused on
the development of antiosteoporotic drugs.
As osteoporosis results due to imbalance in

Table 3 : Number of patients (%) with adverse events in

control and teriparatide groups

Table 2 : Percentage of change in DXA scores from

baseline to 6 months
DXA Parameter Percentage of change

Lumbar spine T-Score
Lumbar spine bone area
Lumbar spine BMC
Total hip TScore
Lumbar spine BMD
Total hip bone area
Total hip BMC
Femoral neck T Score
Femoral neck BMD
Femoral neck bone area
Femoral neck BMC

Control

Teriparatide

-1.46 9.07
-0.20 4.72
0.74 7.76
-6.03 17.21
1.06 4.81
2.04 7.06
4.02 11.02
-2.58 17.20
2.12 5.92
-1.26 6.46
0.79 6.34

-11.30 9.39*
2.05 3.73**
9.44 9.17*
-8.12 12.12
6.58 6.50*
1.33 5.28
3.96 7.54
-4.87 9.30
1.97 4.25
1.38 5.96
3.12 7.0

*P=0.001; **P=0.03; Values are mean SD

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Fig. 2 : Mean percentage change in serum BSAP (A), osteocalcin (B)

and urinary DPD (C) levels at 3 months and 6 months over baseline (*
P<0.05; **P<0.01; *** P<0.02; **** P<0.001). Error bars
indicate SE

Adverse Events


Fever
General weakness
Headache
Body pains
Skin rash
Boils and wounds
Vertigo
Peripheral neuropathy
Cataract
Total number of adverse
events
Total number of patients
with adverse events

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Control
Group
(n=41)

Teriparatide
Group
(n=41)

1 (2.4%)
0
0
5 (12.2%)
2 (4.8%)
2 (4.8%)
0
1 (2.4%)
0
11

2 (4.8%)
2 (4.8%)
4 (9.8%)
7 (17.1%)
1 (2.4%)
0
1 (2.4%)
0
1 (2.4%)
18

9 (21.9%)

9 (21.9%)

421

bone formation and bone resorption, ideally, an

antiosteoporotic drug should increase bone formation
compared to bone resorption. Most current therapies
for osteoporosis, including the bisphosphonates,
hormone replacement therapy, selective oestrogen
receptor modulators and calcitonin, act by reducing
bone turnover. Since patients with osteoporosis have
lost skeletal mass of more than 25% of the normal,
even with treatment with these drugs, many patients
continue to have a BMD that remains within the
osteoporotic range, and many continue to have the
risk to fracture.12 In contrast, anabolic agents such
as teriparatide increase bone formation over bone
resorption, and as a result, increase BMD, thereby
reducing the fracture risks.13,14 Apart from differences
in ethnicity, environmental factors such as low dietary
calcium intake and widespread vitamin D deficiency,
are known to affect skeletal health. Indeed, it is reported
that BMD is approximately 15% lower and fractures
occur 10 20 years earlier in Indians than in the western
population.8,10 In view of these reasons, the current study
has been undertaken to evaluate the efficacy and safety
of teriparatide in Indian postmenopausal women.
The present study is a randomised, open-label,
prospective, multicentre, controlled trial. Placebocontrolled studies are widely accepted as the ideal way
of obtaining unbiased estimates of treatments. However,
this trial is not a placebo-controlled study; both groups
of patients were supplemented with calcium and
vitamin D during the entire study period. In spite of
their historical value in efficacy evaluation, conducting
placebo-controlled clinical trials are currently under
debate. The World Medical Association has recently
revised Declaration of Helsinki, condemning the use
of placebo in studies when established therapies are
available.15 Besides, the prevailing opinion is that new
therapeutic agents should be evaluated in comparison
to current treatments to demonstrate equivalence,
non-inferiority or superiority.16 Long term studies,
including Cochrane meta-analysis, showed a beneficial
effect of supplementation of calcium and vitamin D in
prevention of hip and non-vertebral fractures among
elderly women.17 On the basis of these studies, the
control group of patients were supplemented with
calcium and vitamin D during the entire study period
of 6 months instead of a placebo.
In the current study, 82 postmenopausal women
with osteoporosis, who met the eligibility criteria, were
randomly assigned to two groups control group or
teriparatide group. Both groups of patients had similar
baseline demographic and biochemical characteristics
as well as bone parameters as assessed by DXA, thereby
confirming the effective application of randomised
block design. Among the 82 patients randomised, 73
patients (89%) completed the study and only 9 patients
(11%) were lost to follow-up 6 patients (14.6%) in
422

control group and 3 patients (7.3%) in teriparatide

group. Compliance to medication was closely monitored
throughout the study period. Not only was there an
excellent compliance to oral medication comprising
calcium and vitamin D supplementation (97.7%),
there was also similar compliance to daily injections
in teriparatide group of patients (97.4%), since the
drug was well tolerated and there were minimal side
effects.
After treatment for 6 months, there were no significant
differences in absolute DXA scores (T-scores, BMD,
BMC and bone area) between control and teriparatide
group patients for any of the sites viz., lumbar spine,
total hip and femoral neck (results not presented). The
primary endpoint considered in this was the percentage
of change in lumbar spine (L1-L4) BMD at 6 months over
baseline. Teriparatide treatment for 6 months resulted in
6.58 6.50% increase in lumbar spine BMD compared
to 1.06 4.81% increase in control group patients.
This difference was highly significant (P<0.001). These
results are in conformity with published studies.14,18,19
Since changes in BMD are related to 30-41% reduction
in fracture risk,20 observed increase in lumbar spine
BMD with osteoporosis is likely to result in reduced
risk of vertebral fractures. In addition, teriparatide
produced a significant change in lumbar spine T-score,
BMC and bone area compared to that in control group
of patients. However, there were no significant changes
in total hip and femoral neck BMD between control and
teriparatide treated patients. It has been shown that
in lumbar spine, which is a predominantly trabecular
bone, teriparatide acts differently from that of hip,
which roughly contains equal amounts of cortical and
trabecular bone.12 Disparate effects of teriparatide on
trabecular and cortical bone may explain differences in
its effects on lumbar and hip BMD.
Both BMD as well as biochemical markers of bone
turnover have been used in clinical practice and in
research in osteoporosis. Results of the study have
shown that teriparatide treatment significantly increases
all bone biomarkers of both bone formation (serum
BSAP, serum OC) and resorption (urinary DPD) at 3
months and 6 months over baseline, thereby showing
that administration of teriparatide significantly increased
bone turnover. Recently, NIH Workshop evaluated the
role of biomarkers as surrogate endpoints in clinical
trials and concluded that the combined information
from biomarkers and clinical outcomes provides
strongest rationale for optimal use of interventions.21
In view of this, apart from changes in BMD which is a
primary endpoint, information on percentage of change
in biomarkers of bone formation and bone resorption
at 3 months and 6 months over baseline was collected
as secondary endpoint.
In this study, the efficacy of teriparatide in reducing
the risk of vertebral fractures, which is considered as

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JAPI VOL. 56 JUNE 2008

a gold standard in the assessment of antiosteoporotic

drugs, has not been evaluated. In this context, it needs to
be noted that even in high risk populations, fractures are
too infrequent, and therefore, extremely large sample
size would be required to detect meaningful differences
between control and therapeutic agent treated groups,
using fracture end points. In view of this, in a recent
report, the Surgeon General of US also specifically
recommended the value of BMD and bone biomarker
measures as surrogates for fracture efficacy in clinical
trials of therapeutic agents.22
Treatment with teriparatide for 6 months was safe
and well tolerated. Only minor side effects such as
headache, nausea, dizziness, leg cramps were reported.
Despite the rigorous daily subcutaneous injection
regimen, compliance was excellent. It has not produced
any severe or serious adverse events. The frequency
of adverse events and the number of patients with
adverse events between control and teriparatide group
were also not statistically different thereby showing
that teriparatide is a safe drug for the treatment of
osteoporosis. Often, hypercalcemia has been reported in
a minority (about 10%) of patients during treatment with
teriparatide. In such cases, reduction in calcium intake or
teriparatide dose has been recommended. However, in
the current study, none of the patients in the teriparatide
group developed hypercalcemia, probably because of
low calcium dietary intake which is common among
Indians. As a result, there was no need to reduce the
dose of teriparatide in any of the patients.
Majority of drugs currently available for the treatment
of osteoporosis are based on reducing the resorption
rather than increasing the formation of bone. Despite
the availability of these drugs, many patients continue
to fracture while on therapy either due to inadequate
increase in BMD or are unable to tolerate the drugs23,24
Therefore, there is a place in treatment armamentarium
for the new bone formation agents such as teriparatide
with proven efficacy. Available evidence shows that
teriparatide increased BMD at most sites and decreased
non-vertebral fractures more than antiresorptive drugs
such as alendronate.14,25 Teriparatide being an anabolic
drug, increases lumbar spine BMD, BMC, thereby
showing that it would be an ideal drug for the treatment
of osteoporosis. The only limitation of its use is that like
insulin, it needs to be administered subcutaneously
daily.
Acknowledgements
The authors gratefully acknowledge Dr. Ambarish
Mithal from Apollo Indraprastha Hospital, New
Delhi for participating in the investigators meeting
and assisting in the design of the study. In addition
to the authors, the following members participated in
the study: Dr. TC Raghuram, Mr. AN Naidu, Mr. K
Anand, Ms. T Vishaly and Ms. P Sirisha (Coordinating
Committee members); Dr. Mazher Ali (CARE Hospital,
JAPI VOL. 56 JUNE 2008

Hyderabad); Dr. RS Joshi (PD Hinduja Hospital and

Medical Research Centre, Mumbai); Dr. Abhyudaya
Varma (Medwin Hospital, Hyderabad); Dr. Sanjay
C Reddy (MS Ramaiah Medical College, Bangalore);
Dr. Pankaj Dhar (Apollo Hospitals, Hyderabad); Dr.
Shriraam Mahadevan and Dr. JV Srinivas (Apollo
Hospitals, Chennai). Funding: This research was
supported by Virchow Biotech.

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