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Trial record 24 of 232 for:    CALCITONIN SALMON

A Study of the Treatment of Postmenopausal Women With Osteoporosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00543023
Recruitment Status : Completed
First Posted : October 12, 2007
Last Update Posted : October 12, 2007
Sponsor:
Information provided by:
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE October 10, 2007
First Posted Date  ICMJE October 12, 2007
Last Update Posted Date October 12, 2007
Study Start Date  ICMJE June 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October 10, 2007)
to compare the effect of treatment with teriparatide 20 micrograms/day subcutaneous with that of salmon calcitonin 100 IU/day subcutaneous on change in lumbar spine BMD in postmenopausal women with established osteoporosis.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2007)
  • to compare the effect of treatment with teriparatide 20 micrograms/day with that of calcitonin 100 IU/day on change in femoral neck and total hip BMD in postmenopausal women with established osteoporosis
  • to compare the effect of treatment with teriparatide 20 micrograms/day with that of calcitonin 100 IU/day on change in biochemical bone markers (bone specific alkaline phosphatase [BSAP] and Osteocalcin) at 3 and 6 months
  • to assess safety as determined by physical examination, vital signs, clinical laboratory data and reports of adverse events.
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 A Study of the Treatment of Postmenopausal Women With Osteoporosis
Official Title  ICMJE Comparison of Teriparatide and Calcitonin in the Treatment of Postmenopausal Women With Osteoporosis
Brief Summary To compare the effect of treatment with teriparatide with that of salmon calcitonin in postmenopausal women with osteoporosis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Osteoporosis, Post-Menopausal
Intervention  ICMJE
  • Drug: teriparatide 20 micrograms/day subcutaneous
    Other Name: LY333334
  • Drug: salmon calcitonin 100 IU/day subcutaneous
Study Arms  ICMJE
  • Experimental: A
    teriparatide 20 micrograms/day subcutaneous
    Intervention: Drug: teriparatide 20 micrograms/day subcutaneous
  • Active Comparator: B
    salmon calcitonin 100 IU/day subcutaneous
    Intervention: Drug: salmon calcitonin 100 IU/day subcutaneous
Publications * Not Provided

*   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: October 10, 2007)
104
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Ambulatory, postmenopausal women aged 55-85 years (at least 3 years have elapsed after menopausal) are included at the time of entry into the trial. They have to be free of severe or chronically disabling conditions other than osteoporosis.
  • The patient should have a documented (X-ray) prevalent osteoporotic vertebral fracture or non-vertebral fragility fracture (excluding major trauma). Vertebral deformities will be evaluated on lateral views of the thoracic and lumbar spine. T-12 will be visible on both views so that all vertebrae from T-4 to L-4 can be identified. The radiographs will be performed according to a standardized protocol.
  • L-1 through L-4 vertebrae must be without artifacts, multiple vertebral fractures; therefore at least 3 vertebrae should be without fractures, osteophytes, or other abnormalities that would interfere with the analysis of the posterior-anterior lumbar spine BMD measurement. The reading of the BMD, T-score should be in the range of - 2.0 and - 4.0 at least for one of the 2 sites measured (spine or hip).

The initial lumbar spine and femoral neck BMD assessment and the determination of the patient's eligibility for entry into the screening phase will be made by the central quality assurance for BMD. The central quality assurance center will determine the patient's eligibility for enrollment into the treatment phase. If the L-1 vertebra cannot be analyzed due to artifacts, vertebral fracture, osteophytes, or other abnormalities, that vertebra should be excluded from the analysis.

  • Women without language barriers, cooperative and expected to return for all follow-up procedures and who have given informed consent before entering the study and after being informed of the risks, medications, and procedures to be used in the study.
  • Normal or clinically insignificant abnormal laboratory values including serum calcium, PTH (1-84) levels and alkaline phosphatase.

Exclusion Criteria:

  • History of sprue, inflammatory bowel disease, or malabsorption syndrome in the 1 year prior to Visit 2.
  • History of nephrolithiasis or urolithiasis in the 2 years prior to Visit 2. Patients with any history of nephro- or urolithiasis must have an appropriate radiology study within 6 months prior to Visit 2. This radiology study, such as an intravenous pyelogram or a supine radiograph of the kidney-ureter-bladder, must document the absence of active disease.
  • History of other malignant neoplasms in the 5 years prior to screening, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated. Patients with carcinoma in situ of the uterine cervix treated definitively more than 1 year prior to entry into the study may enter the study.
  • Patients who have an increased baseline risk of osteosarcoma: Paget's disease of the bone or unexplained elevations of alkaline phosphatase; patients who have received radiation therapy involving the skeleton.
  • History of diseases which affect bone metabolism other than postmenopausal osteoporosis such as Paget's disease, renal osteodystrophy, osteomalacia, any secondary causes of osteoporosis, hypoparathyroidism, hyperparathyroidism, or hyperthyroidism.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 55 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 China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00543023
Other Study ID Numbers  ICMJE 6972
B3D-AA-GHCF
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Call 1-877-CTLILLY (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 October 2007

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