Effects of Teriparatide in the Treatment of Postmenopausal Women With Osteoporosis
NCT ID: NCT00670501
Last Updated: 2008-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1637 participants
INTERVENTIONAL
1996-08-31
1999-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
LY333334 40 micrograms/day plus calcium and vitamin D
teriparatide
40 micrograms/day subcutaneous injection for 3 years with optional 2 year extension phase
Calcium Supplement
Approximately 1000 mg/day of elemental calcium will be supplied as open-label oral supplement
Vitamin D Supplement
Approximately 400 to 1200 IU/day of vitamin D will be supplied as open-label oral supplement
2
LY333334 20 micrograms/day plus calcium and vitamin D
teriparatide
20 micrograms/day subcutaneous injection for 3 years with optional 2 year extension phase
Calcium Supplement
Approximately 1000 mg/day of elemental calcium will be supplied as open-label oral supplement
Vitamin D Supplement
Approximately 400 to 1200 IU/day of vitamin D will be supplied as open-label oral supplement
3
Placebo plus calcium and vitamin D
Placebo
Placebo for subcutaneous injection will be supplied in a prefilled injection device with a cartridge identical in appearance to the LY333334 device.
Calcium Supplement
Approximately 1000 mg/day of elemental calcium will be supplied as open-label oral supplement
Vitamin D Supplement
Approximately 400 to 1200 IU/day of vitamin D will be supplied as open-label oral supplement
Interventions
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teriparatide
40 micrograms/day subcutaneous injection for 3 years with optional 2 year extension phase
teriparatide
20 micrograms/day subcutaneous injection for 3 years with optional 2 year extension phase
Placebo
Placebo for subcutaneous injection will be supplied in a prefilled injection device with a cartridge identical in appearance to the LY333334 device.
Calcium Supplement
Approximately 1000 mg/day of elemental calcium will be supplied as open-label oral supplement
Vitamin D Supplement
Approximately 400 to 1200 IU/day of vitamin D will be supplied as open-label oral supplement
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
30 Years
85 Years
FEMALE
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Eli Lilly
Principal Investigators
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Call 1-877-CT LILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Boston, Massachusetts, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Capital Federal, , Argentina
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Nedlands, , Australia
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Graz, , Austria
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Brussels, , Belgium
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Calgary, Alberta, Canada
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Prague, , Czechia
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Aarhus, , Denmark
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Kuopio, , Finland
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Szeged, , Hungary
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Tel Litwinsky, , Israel
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Arenzano, , Italy
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Amsterdam, , Netherlands
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Christchurch, , New Zealand
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Kristiansand, , Norway
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Warsaw, , Poland
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Uppsala, , Sweden
Countries
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References
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Prevrhal S, Krege JH, Chen P, Genant H, Black DM. Teriparatide vertebral fracture risk reduction determined by quantitative and qualitative radiographic assessment. Curr Med Res Opin. 2009 Apr;25(4):921-8. doi: 10.1185/03007990902790993.
Other Identifiers
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B3D-MC-GHAC
Identifier Type: -
Identifier Source: secondary_id
547
Identifier Type: -
Identifier Source: org_study_id