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

Virchow Group82 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Osteoporosis

Interventions

OsteoformDRUG

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

SHELCALDRUG

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

Eligibility

Sex: FEMALEMin age: 45 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (6)

Apollo Hospitals

Hyderabaad, Andhra Pradesh, India

CARE Hospitals

Hyderabaad, Andhra Pradesh, India

Medwin Hospital

Hyderabaad, Andhra Pradesh, India

MS Ramaiah Medical College

Bangalore, Karnataka, India

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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