OsteoporosisPhase 3NCT00500409

Safety and Efficacy of OSTEOFORM (rhPTH [1-34]) in Increasing Bone Mineral Density in Osteoporosis

A Phase 3 study testing Osteoform and SHELCAL in people with Osteoporosis, run by Virchow Group at 6 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

OSTEOFORM, containing recombinant (rhPTH [1-34]), enhances bone mineral density and reduces risk for vertebral fracture. This study evaluates the safety and efficacy of OSTEOFORM in the treatment of osteoporosis in post-menopausal women. Read more about this study

Who is it for?: Ages 45 to 75 years, women only
Conditions the study is for: Osteoporosis
What is being tested?: Osteoform and SHELCAL
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 82 participants
Where: 6 sitesIndia
Study dates: Dec 2005to Jul 2007
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 to 75 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Postmenopausal women with osteoporosis (Lumbar spine or femoral neck BMD or total hip T-score less than or equal to-2.5)

Who cannot join

Women with vertebral (L1-L4) abnormalities that preclude accurate measurement by DEXA.
Women on medications that are known to affect bone for more than 7 days in the past 6 months.
Currently taking systemic prednisone, inhaled steroids, anticoagulants, anticonvulsants.
History of rhPTH use or known hypersensitivity to study drug.
Vitamin D3 deficiency (Vitamin D3 < 20 ng/ml).
Abnormal thyroid function.

Show all 9Show fewer

History of kidney disease.
Any history of hypercalciuria, hypercalcemia or hyperparathyroidism.
History of active or treated tuberculosis or significant liver disease or gastrointestinal disease or cancer.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

India6 sites

MS Ramaiah Medical College
Bangalore, Karnataka
Apollo Hospitals
Chennai, Tamil Nadu
Apollo Hospitals
Hyderabaad, Andhra Pradesh
CARE Hospitals
Hyderabaad, Andhra Pradesh
Medwin Hospital
Hyderabaad, Andhra Pradesh
P.D. Hinduja Hospital and Medical Research Center
Mumbai, Maharashtra

Other trials in India

About this study

Official title: Safety and Efficacy of OSTEOFORM (rhPTH [1-34]) in Increasing Bone Mineral Density in Osteoporosis. A Randomized Controlled Open-label Multicentre Study in India

Read the detailed description

207 post-menopausal women were enrolled for screening at 6 centres, and supplemented with daily 1000 mg elemental calcium and 500 IU of vitamin D for 45 days. 82 eligible women with osteoporosis were randomly received daily either calcium and vitamin D alone (control group) or Osteoform 20 µg subcutaneously with calcium and vitamin D (drug group) for 12 months. End points such as percentage of increase in bone mineral density and, changes in bone biomarkers (serum osteocalcin, bone specific alkaline phosphatase, and urinary DPD) were evaluated at baseline, and 6 and 12 months after supplementation. Besides, safety parameters and adverse events were monitored through out the study period.

Conditions: Osteoporosis
Being tested: Osteoform, SHELCAL
Keywords: rhPTH(1-34), Osteoporosis
Medical subject headings: Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OsteoformDrug
Administer Osteoform 20 µg daily subcutaneously and 1000 mg calcium and 500 IU vitamin D orally for 180 days
SHELCALDrug
Also called Calcium and vitamin D
Administer calcium and vitamin D (1000 mg calcium and 500 IU vitamin D) orally for 180 days

Study groups in NCT00500409
Study group	Role	What they receive
Drug Group	Experimental	Osteoform Receives: Drug: Osteoform
Control group	Active comparator	SHELCAL Receives: Drug: SHELCAL

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of change in Bone Mineral Density at lumber spine (L1-L4) in postmenopausal women with osteoporosis at the end of 6 and 12 months.
Measured: 6 and 12 months

Secondary outcomes (1)

Percentage of change from baseline in biomarkers of bone formation and bone resorption at the end of 3, 6 and 12 months.
Measured: 3, 6 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2005Jul 2007

First posted12 Jul 2007 (estimated)
Study startDec 2005
Primary completionDec 2006
Study completionJul 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for OsteoporosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 82 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00500409
Sponsor's protocol ID: VB006/05
Status last verified: Jul 2007
First submitted: 11 Jul 2007
Last updated: 16 Dec 2014
Results posted: No
Data monitoring committee: No

Publications

Sethi BK, Chadha M, Modi KD, Kumar KM, Mehrotra R, Sriram U. Efficacy of teriparatide in increasing bone mineral density in postmenopausal women with osteoporosis--an Indian experience. J Assoc Physicians India. 2008 Jun;56:418-24.
PubMed 18822620

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Romosozumab and Denosumab Combination Therapy for Osteoporosis
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All Osteoporosis trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy of OSTEOFORM (rhPTH [1-34]) in Increasing Bone Mineral Density in Osteoporosis. A Randomized Controlled Open-label Multicentre Study in India
ClinicalTrials.gov ID: NCT00500409
Acronym / sponsor ID: VB006/05
Conditions: Osteoporosis
Keywords: rhPTH(1-34), Osteoporosis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 82 participants (actual)
Lead sponsor: Virchow GroupIndustry (pharma, biotech, devices)
Study start: Dec 2005
Primary completion: Dec 2006 (actual)
Study completion: Jul 2007 (actual)
First posted: 12 Jul 2007 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Drug Group	Experimental	Drug: OsteoformOsteoform
Control group	Active comparator	Drug: SHELCALSHELCAL

Who may qualify

Ages: 45 to 75 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Postmenopausal women with osteoporosis (Lumbar spine or femoral neck BMD or total hip T-score less than or equal to-2.5)

Key exclusion criteria (9 listed)

Women with vertebral (L1-L4) abnormalities that preclude accurate measurement by DEXA.
Women on medications that are known to affect bone for more than 7 days in the past 6 months.
Currently taking systemic prednisone, inhaled steroids, anticoagulants, anticonvulsants.
History of rhPTH use or known hypersensitivity to study drug.
Vitamin D3 deficiency (Vitamin D3 < 20 ng/ml).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OsteoformAdminister Osteoform 20 µg daily subcutaneously and 1000 mg calcium and 500 IU vitamin D orally for 180 days	Drug	Drug Group
SHELCALAlso: Calcium and vitamin DAdminister calcium and vitamin D (1000 mg calcium and 500 IU vitamin D) orally for 180 days	Drug	Control group

Primary outcome

Percentage of change in Bone Mineral Density at lumber spine (L1-L4) in postmenopausal women with osteoporosis at the end of 6 and 12 months.
Time frame: 6 and 12 months

1 secondary outcome

Percentage of change from baseline in biomarkers of bone formation and bone resorption at the end of 3, 6 and 12 months.
Time frame: 3, 6 and 12 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2014.
Derived from this study: PubMed 18822620Sethi BK, Chadha M, Modi KD, Kumar KM, Mehrotra R, Sriram U. Efficacy of teriparatide in increasing bone mineral density in postmenopausal women with osteoporosis--an Indian experience. J Assoc Physicians India. 2008 Jun;56:418-24.

Related trials for Osteoporosis

RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Active, not recruitingPhase 2
TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status
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Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
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RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dr. Bipin Kumar Sethi, MD, DM principal investigator

CARE Hospitals, Hyderabad, AP, India

Dr. Manoj Chadha, MD, DM principal investigator

P.D. Hinduja Hospital and Medical Research Centre, Mumbai, India

Dr. K.Prasanna Kumar, MD, DM principal investigator

M.S. Ramaiah Medical College, Bangalore, India

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Osteoform and SHELCAL in people with Osteoporosis, run by Virchow Group at 6 sites in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of change in Bone Mineral Density at lumber spine (L1-L4) in postmenopausal women with osteoporosis at the end of 6 and 12 months. (time frame: 6 and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00500409, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2014.