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Effects of Teriparatide in the Treatment of Postmenopausal Women With Osteoporosis

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ClinicalTrials.gov Identifier: NCT00670501
Recruitment Status : Completed
First Posted : May 1, 2008
Last Update Posted : May 1, 2008
Sponsor:
Information provided by:
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE April 29, 2008
First Posted Date  ICMJE May 1, 2008
Last Update Posted Date May 1, 2008
Study Start Date  ICMJE August 1996
Actual Primary Completion Date April 1999   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2008)
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. [ Time Frame: Baseline, randomization, 24 , 36, and 60 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2008)
  • 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 [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: Randomization, 12, 24, 36, 48, and 60 months ]
  • To determine the histomorphometric effects of LY333334 plus calcium & vitamin D, compared with calcium & vitamin D alone by biopsy, on the iliac crest (bone formation & resorption, mineralization, and trabecular structure) in a subset of subjects. [ Time Frame: Randomization, 12 and 24 months ]
  • To assess effects of LY333334 plus calcium & vitamin D, compared with calcium & vitamin D alone, on biochemical markers of bone formation & resorption (bone-specific alkaline phosphatase, PICP, urinary N-telopeptide, & urinary free deoxypyridinolines) [ Time Frame: Randomization, 1, 3, 6, 12, 24, 36, 48, and 60 months ]
  • To assess population pharmacokinetics of LY333334 at selected study sites. Nonlinear mixed effect modeling [NONMEM])and or PTH(1-84) will be employed to evaluate serum concentrations of LY333334. [ Time Frame: Months 1, 3, 6, 12, 18, 24, 30, 36 and 60 ]
  • To quantify medical resources used by patients during the study so that a cost-effectiveness analysis can be performed. [ Time Frame: Randomization, 6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 Months ]
  • To assess the impact of LY333334 on health-related quality of life in postmenopausal women with osteoporosis. Quality of life instruments will be completed where translated and validated instruments are available. [ Time Frame: Randomization, 12, 24, 36, 48, and 60 months ]
  • To establish the safety of chronic administration of LY333334 in postmenopausal women with osteoporosis. Adverse events, physical examinations and laboratory tests will be used to assess safety in the patients. [ Time Frame: Adverse Events: throughout the trial. Labs:Baseline, randomization, 1, 6, 12, 24, 36, 48, and 60 months. Physical Exams: 12, 24, 36, 48, and 60 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Teriparatide in the Treatment of Postmenopausal Women With Osteoporosis
Official Title  ICMJE Effects of LY333334 in the Treatment of Postmenopausal Women With Osteoporosis
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Osteoporosis, Postmenopausal
Intervention  ICMJE
  • Drug: teriparatide
    40 micrograms/day subcutaneous injection for 3 years with optional 2 year extension phase
    Other Names:
    • LY333334
    • Forteo
    • Forsteo
  • Drug: teriparatide
    20 micrograms/day subcutaneous injection for 3 years with optional 2 year extension phase
    Other Names:
    • LY333334
    • Forteo
    • Forsteo
  • Drug: Placebo
    Placebo for subcutaneous injection will be supplied in a prefilled injection device with a cartridge identical in appearance to the LY333334 device.
  • Drug: Calcium Supplement
    Approximately 1000 mg/day of elemental calcium will be supplied as open-label oral supplement
  • Drug: Vitamin D Supplement
    Approximately 400 to 1200 IU/day of vitamin D will be supplied as open-label oral supplement
Study Arms  ICMJE
  • Experimental: 1
    LY333334 40 micrograms/day plus calcium and vitamin D
    Interventions:
    • Drug: teriparatide
    • Drug: Calcium Supplement
    • Drug: Vitamin D Supplement
  • Experimental: 2
    LY333334 20 micrograms/day plus calcium and vitamin D
    Interventions:
    • Drug: teriparatide
    • Drug: Calcium Supplement
    • Drug: Vitamin D Supplement
  • Placebo Comparator: 3
    Placebo plus calcium and vitamin D
    Interventions:
    • Drug: Placebo
    • Drug: Calcium Supplement
    • Drug: Vitamin D Supplement
Publications * 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 .

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 29, 2008)
1637
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 1999
Actual Primary Completion Date April 1999   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 30 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Canada,   Czech Republic,   Denmark,   Finland,   Hungary,   Israel,   Italy,   Netherlands,   New Zealand,   Norway,   Poland,   Sweden,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00670501
Other Study ID Numbers  ICMJE 547
B3D-MC-GHAC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chief Medical Officer, Eli Lilly
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: 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) Eli Lilly and Company
PRS Account Eli Lilly and Company
Verification Date April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP