Safety and Efficacy of OSTEOFORM (rhPTH [1-34]) in Increasing Bone Mineral Density in Osteoporosis. A Randomized Controlled Open-label Multicentre Study in India
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 5
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women with osteoporosis (Lumbar spine or femoral neck BMD or total hip T-score less than or equal to-2.5)
排除标准
- •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.
研究组 & 干预措施
Drug Group
Osteoform
干预措施: Osteoform (Drug)
Control group
SHELCAL
干预措施: SHELCAL (Drug)
结局指标
主要结局
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.
时间窗: 6 and 12 months
次要结局
- Percentage of change from baseline in biomarkers of bone formation and bone resorption at the end of 3, 6 and 12 months.(3, 6 and 12 months)