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

NCT00500409 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2014-12-16

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Osteoform

Administer Osteoform 20 µg daily subcutaneously and 1000 mg calcium and 500 IU vitamin D orally for 180 days

DRUG

SHELCAL

Administer calcium and vitamin D (1000 mg calcium and 500 IU vitamin D) orally for 180 days

Sponsors & Collaborators

  • Virchow Group

    lead INDUSTRY

Principal Investigators

  • Dr. Bipin Kumar Sethi, MD, DM · CARE Hospitals, Hyderabad, AP, India

  • Dr. Manoj Chadha, MD, DM · P.D. Hinduja Hospital and Medical Research Centre, Mumbai, India

  • Dr. K.Prasanna Kumar, MD, DM · M.S. Ramaiah Medical College, Bangalore, India

  • Dr. K.D. Modi, MD, DM · Medwin Hospital, Hyderabad, AP, India

  • Dr. Rabinderanath Mehrotra, MD, DM · Apollo Hospitals, Hyderabad, AP, India

  • Dr. Usha Sriram, MD, DM · Apollo Hospitals, Chennai, India

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2006-12-31
Completion
2007-07-31

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00500409 on ClinicalTrials.gov