Effects of Teriparatide in the Treatment of Postmenopausal Women With Osteoporosis

Effects of LY333334 in the Treatment of Postmenopausal Women With Osteoporosis

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.

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.