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

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.

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

• Women with vertebral (L1-L4) abnormalities that preclude accurate measurement by DEXA.
• Women on medications that are known to affect bone for more than 7 days in the past 6 months.
• Currently taking systemic prednisone, inhaled steroids, anticoagulants, anticonvulsants.
• History of rhPTH use or known hypersensitivity to study drug.
• Vitamin D3 deficiency (Vitamin D3 < 20 ng/ml).
• Abnormal thyroid function.
• History of kidney disease.
• Any history of hypercalciuria, hypercalcemia or hyperparathyroidism.
• History of active or treated tuberculosis or significant liver disease or gastrointestinal disease or cancer.