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

This study has been completed.
Sponsor:
Information provided by:
Virchow Group
ClinicalTrials.gov Identifier:
NCT00500409
First received: July 11, 2007
Last updated: NA
Last verified: July 2007
History: No changes posted

July 11, 2007
July 11, 2007
December 2005
Not Provided
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
No Changes Posted
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
Not Provided
Not Provided
 
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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Osteoporosis
Drug: OSTEOFORM (rhPTH [1-34]) along with calcium and vitamin D
Not Provided
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
82
July 2007
Not Provided

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.
Female
45 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT00500409
VB006/05
No
Not Provided
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