Clinical trial NCT00670501 (phase 3, status: completed)
Conditions: osteoporosis, postmenopausal
ICD codes: N95.0, N95.2
Drugs: teriparatide, teriparatide, placebo, calcium supplement, vitamin d supplement
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, [Ca++].[Ca++].[Ca++].OC(CC([O-])=O)(CC([O-])=O)C([O-])=O.OC(CC([O-])=O)(CC([O-])=O)C([O-])=O
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.