Skip to content

Trial · Interventional

CompletedPhase 3Registry data

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

NCTNCT00500409 (opens ClinicalTrials.gov in a new tab)Other idVB006/05
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Names Teriparatide (PTH 1-34), does not test it. It appears in the title.

Overview

Status
Completed
Phase
Phase 3
Enrollment
82 participants (actual)
Sponsor
Virchow Group · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

India

Start
Dec 2005
Primary completion
Dec 2006
Completion
Jul 2007
First posted
12 Jul 2007 (estimated)
Last update posted
16 Dec 2014 (estimated)
Conditions
Osteoporosis

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2005200620072008
  1. Ph 3

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

    NCT00500409

    Dec 2005 to Jul 2007

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • OsteoformDrug
  • SHELCALDrug

Arms2

  • Experimental

    Drug Group

    Osteoform

  • Active comparator

    Control group

    SHELCAL

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 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

Secondary outcomes(1)

  1. 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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2008

9 results

Efficacy of teriparatide in increasing bone mineral density in postmenopausal women with osteoporosis--an Indian experience.

Sethi et al. 2008The Journal of the Association of Physicians of Indiacited by 15

PMID 18822620PUB-18822620

Full text at the publisher9 results
Publisher pageSee results (9)

Eligibility

Who could join, as posted.

Sex
Female
Age
from 45 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: Postmenopausal women with osteoporosis (Lumbar spine or femoral neck BMD or total hip T-score less than or equal to-2.5) Exclusion Criteria: 1. Women with vertebral (L1-L4) abnormalities that preclude accurate measurement by DEXA. 2. Women on medications that are known to affect bone for more than 7 days in the past 6 months. 3. Currently taking systemic prednisone, inhaled steroids, anticoagulants, anticonvulsants. 4. History of rhPTH use or known hypersensitivity to study drug. 5. Vitamin D3 deficiency (Vitamin D3 \< 20 ng/ml). 6. Abnormal thyroid function. 7. History of kidney disease. 8. Any history of hypercalciuria, hypercalcemia or hyperparathyroidism. 9. History of active or treated tuberculosis or significant liver disease or gastrointestinal disease or cancer.

PepBank is a research reference. Talk to a doctor before you use any peptide.