effects of teriparatide in the treatment of postmenopausal women with osteoporosis

Conditions: Osteoporosis, Postmenopausal

Summary: the primary objective of this study is to demonstrate a reduction in the proportion of new vertebral fractures in postmenopausal women with osteoporosis following 3-years of treatment with 20 and 40 mcg/day of teriparatide plus calcium and vitamin d compared with calcium and vitamin d alone.


Eligibility criteria:
inclusion criteria: * ambulatory, postmenopausal women. * a minimum of either one moderate or two mild atraumatic vertebral fractures, and a minimum of seven evaluable nonfractured vertebrae. * hip bmd or lumbar spine bmd measurement at least 1.0 standard deviation (sd) below the average bone mass for young, healthy women (t-score) only in patients with fewer than two moderate fractures or in patients previously treated with therapeutic doses of bisphosphonates or fluorides * normal or clinically nonsignificant abnormal laboratory values (serum calcium, pth(1-84), \& urine calcium must be within normal limits at baseline; 25-hydroxyvitamin d must be between the lower limit of normal \& 3 times the upper limit of normal at baseline). exclusion criteria: * fractures in areas of bone affected by diseases other than osteoporosis (for example, cancer or paget's disease). * satisfactory baseline thoracic and lumbar spinal x-ray views cannot be obtained as determined by the centralized x-ray quality assurance center (for example, severe scoliosis or kyphosis). * current or recent (within 1 year prior to randomization) metabolic bone disorders other than postmenopausal osteoporosis, such as paget's disease, renal osteodystrophy, osteomalacia, or any secondary causes of osteoporosis * current or recent (within 1 year prior to randomization) disease which affects bone metabolism, such as hypoparathyroidism, hyperparathyroidism, or hyperthyroidism. * currently suspected carcinoma or history of carcinoma in the 5 years prior to randomization. * nephrolithiasis or urolithiasis in the 2 years prior to randomization. * current or recent (within 1 year prior to randomization) sprue, inflammatory bowel disease, or malabsorption syndrome, or any indication of poor intestinal absorption of calcium, such as the combination of a low urinary calcium excretion and an elevated serum intact parathyroid hormone level. * poor medical or psychiatric risk for treatment with an investigational drug, in the opinion of the investigator. * treatment with androgens or other anabolic steroids in the 6 months prior to randomization. * treatment with calcitonins in the 2 months prior to randomization. * treatment with estrogen * treatment with progestins in the 3 calendar months prior to randomization, or for more than 2 months in the 12 calendar months prior to randomization. * treatment with corticosteroids. * treatment with fluorides in the 6 months prior to randomization or for more than 60 days in the 24 months prior to randomization. * treatment with oral bisphosphonates in the 3 months prior to randomization or for more than 60 days in the 24 months prior to randomization; treatment with intravenous bisphosphonates in the 24 months prior to randomization. * treatment with vitamin d \>50,000 iu/week, or with any dose of calcitriol, analogs, or agonists in the 6 months prior to randomization. the 25-hydroxyvitamin d laboratory value at randomization must be between the lower limit of normal and three times the upper limit of normal. * treatment with coumarins and indandione derivatives in the 3 months prior to randomization; treatment with heparins \>10,000 u/day for more than 30 days in the 6 months prior to randomization. * treatment with calcium- or aluminum-containing antacids * treatment with any other drug known to affect bone metabolism in the 6 months prior to randomization. * treatment with any investigational drug during the month prior to the calcium and vitamin d run-in phase. treatment with investigational drugs in certain therapeutic classes during the month prior to the calcium \& vitamin d run-in phase.