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

This study has been completed.
Information provided by (Responsible Party):
Virchow Group Identifier:
First received: July 11, 2007
Last updated: December 15, 2014
Last verified: July 2007

July 11, 2007
December 15, 2014
December 2005
December 2006   (Final data collection date for 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 ]
Same as current
Complete list of historical versions of study NCT00500409 on Archive Site
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 ]
Same as current
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Safety and Efficacy of OSTEOFORM (rhPTH [1-34]) in Increasing Bone Mineral Density in Osteoporosis
Safety and Efficacy of OSTEOFORM (rhPTH [1-34]) in Increasing Bone Mineral Density in Osteoporosis. A Randomized Controlled Open-label Multicentre Study in India
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.
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.
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • 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
    Other Name: Calcium and vitamin D
  • Experimental: Drug Group
    Intervention: Drug: Osteoform
  • Active Comparator: Control group
    Intervention: Drug: SHELCAL
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 2007
December 2006   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
45 Years to 75 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
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Not Provided
Virchow Group
Virchow Group
Not Provided
Principal Investigator: Dr. Bipin Kumar Sethi, MD, DM CARE Hospitals, Hyderabad, AP, India
Principal Investigator: Dr. Manoj Chadha, MD, DM P.D. Hinduja Hospital and Medical Research Centre, Mumbai, India
Principal Investigator: Dr. K.Prasanna Kumar, MD, DM M.S. Ramaiah Medical College, Bangalore, India
Principal Investigator: Dr. K.D. Modi, MD, DM Medwin Hospital, Hyderabad, AP, India
Principal Investigator: Dr. Rabinderanath Mehrotra, MD, DM Apollo Hospitals, Hyderabad, AP, India
Principal Investigator: Dr. Usha Sriram, MD, DM Apollo Hospitals, Chennai, India
Virchow Group
July 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP