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.
- 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).
- 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
- 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
- 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
- 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.