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NCT00500409
Safety and Efficacy of OSTEOFORM (rhPTH [1-34]) in Increasing Bone Mineral Density in Osteoporosis. A Randomized Controlled Open-label Multicentre Study in India
Phase 3 trial testing Osteoform in Osteoporosis in 82 participants. Completed in 1 July 2007.
1 December 2006
Quick facts
| Lead sponsor | Virchow Group |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 82 |
| Start date | 1 December 2005 |
| Primary completion | 1 December 2006 |
| Estimated completion | 1 July 2007 |
| Sites | 6 locations across India |
Drugs / interventions tested
Conditions studied
- Osteoporosis — all drugs for Osteoporosis →
Sponsor
Virchow Group — full company profile →
Who can join
Adults 45 to 75, female only, with Osteoporosis. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Efficacy of teriparatide in increasing bone mineral density in postmenopausal women with osteoporosis--an Indian experience.
Sethi BK, Chadha M, Modi KD, Kumar KM, et al · · 2008 · cited 14× · PMID 18822620
Verify or expand the search:
- PubMed search for NCT00500409
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Osteoporosis
Currently open trials in the same condition.
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- NCT07281586 — Step-down Therapy After Long-term Osteoporosis Treatment · Phase 4 · recruiting
- NCT07083557 — Routine Validation and Reproducibility Testing of Laboratory Assays and Research Techniques Used for Endocrine, Cardiome · recruiting
Other Virchow Group trials
Trials by the same sponsor.
- NCT07017036 — Efficacy, Safety and Pharmacokinetic of Virchow IVIG in PID Patients · Phase 3 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00500409 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Virchow Group
- Last refreshed: 15 December 2014
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00500409.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing