Conditions

Osteoporosis, Postmenopausal

Outcome Measures

Primary Outcomes (1)

To demonstrate a reduction in the proportion of patients with new vertebral fractures (by spinal x-ray) following 3-year treatment with 20 and 40 micrograms/day of LY333334 plus calcium and vitamin D compared with calcium and vitamin D alone.
Baseline, randomization, 24 , 36, and 60 months

Secondary Outcomes (11)

To establish the effect of long-term treatment with LY333334 plus calcium and vitamin D, compared with calcium and vitamin D alone, on lumbar spine and hip BMD in postmenopausal women with osteoporosis
Lumbar Spine: Randomization -2wks, Randomization,( 3 & 6 months in a subset of pts), 12 , 18 , 24 , 36 , 48 & 60 months. Hip BMD: Randomization -2wks, Randomization, 12 , 24 , 36 , 48 & 60 months.
To establish the effect of long-term treatment with LY333334 plus calcium and vitamin D, compared with calcium and vitamin D alone, on total body and radial (forearm) BMD in postmenopausal women with osteoporosis at selected study sites
Randomization, 12, 24, 36, 48 and 60 months
To establish the effect of long-term treatment with LY333334 plus calcium and vitamin D, compared with calcium and vitamin D alone, on the rate of new vertebral fractures (by spinal x-ray) in postmenopausal women with osteoporosis.
Baseline, randomization, 24 months, 60 months
To establish the effect of treatment with LY333334 plus calcium & vitamin D, compared with calcium & vitamin D alone, by x-ray on the proportion of subjects experiencing new nonvertebral fractures alone & new nonvertebral & vertebral fractures combined.
As clinically needed throughout the trial
To assess the effect of long-term treatment with LY333334 plus calcium and vitamin D, compared with calcium and vitamin D alone, on height (via Harpenden stadiometer or other suitable stadiometer) in postmenopausal women with osteoporosis
Randomization, 12, 24, 36, 48, and 60 months
+6 more secondary outcomes

Study Arms (3)

1

EXPERIMENTAL

LY333334 40 micrograms/day plus calcium and vitamin D

Drug: teriparatideDrug: Calcium SupplementDrug: Vitamin D Supplement

2

EXPERIMENTAL

LY333334 20 micrograms/day plus calcium and vitamin D

Drug: teriparatideDrug: Calcium SupplementDrug: Vitamin D Supplement

3

PLACEBO COMPARATOR

Placebo plus calcium and vitamin D

Drug: PlaceboDrug: Calcium SupplementDrug: Vitamin D Supplement

Interventions

teriparatideDRUG

40 micrograms/day subcutaneous injection for 3 years with optional 2 year extension phase

Also known as: LY333334, Forteo, Forsteo

1

PlaceboDRUG

Placebo for subcutaneous injection will be supplied in a prefilled injection device with a cartridge identical in appearance to the LY333334 device.

3

Calcium SupplementDRUG

Approximately 1000 mg/day of elemental calcium will be supplied as open-label oral supplement

123

Vitamin D SupplementDRUG

Approximately 400 to 1200 IU/day of vitamin D will be supplied as open-label oral supplement

123

Eligibility Criteria

Age30 Years - 85 Years

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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).

You may not qualify if:

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.
+5 more criteria

Contact the study team to confirm eligibility.