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

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Virchow Group
• Treatments: Calcium, Dietary; Ergocalciferols; Vitamin D; Vitamins

Criteria

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.