Comparison Medications in the Treatment of Postmenopausal Women With Osteoporosis

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00542984
First received: October 10, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted

October 10, 2007
October 10, 2007
August 2003
Not Provided
To compare in postmenopausal women with established osteoporosis the effect of treatment with teriparatide 20 micrograms/day subcutaneous with the effect of salmon calcitonin 100 IU/day subcutaneous on change in lumbar spine BMD.
Same as current
No Changes Posted
  • To compare in postmenopausal women with established osteoporosis the effect of treatment with teriparatide 20 micrograms/day with the effect of calcitonin 100 IU/day on change in femoral neck and total hip BMD
  • Compare effect of teriparatide 20 micrograms/day with the effect of calcitonin 100 IU/day on change in biochemical bone markers (bone specific alkaline phosphatase and Osteocalcin) at 3 and 6 months after treatment with teriparatide versus calcitonin.
  • Safety as determined by physical examinations, vital signs, clinical labs and reports of adverse events
Same as current
Not Provided
Not Provided
 
Comparison Medications in the Treatment of Postmenopausal Women With Osteoporosis
Comparison of Teriparatide and Calcitonin in the Treatment of Postmenopausal Women With Osteoporosis

To compare in postmenopausal women with established osteoporosis the effect of treatment with teriparatide 20 micrograms/day subcutaneous with the effect of salmon calcitonin 100 IU/day subcutaneous on change in lumbar spine BMD.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Osteoporosis, Postmenopausal
  • Drug: teriparatide 20 micrograms/day subcutaneous
    Other Name: LY333334
  • Drug: salmon calcitonin 100 IU/day subcutaneous
  • Active Comparator: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
November 2004
Not Provided

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 (defined as 3.4) or non vertebral fragility fracture (excluding major trauma).
  • 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 through L-4 vertebrae cannot be analyzed due to artifacts, vertebral fracture, osteophytes, or other abnormalities, that vertebra should be excluded from the analysis.
  • Women without language barrier, cooperative 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 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.
  • Patients who have an increased baseline risk of osteosarcoma: Paget's disease of the bone or unexplained elevations of alkaline phosphatase; Children and young adult with open epiphyses; Patients who have received radiation therapy involving the skeleton.
  • 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.
  • 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 sprue, inflammatory bowel disease, or malabsorption syndrome in the 1 year prior to Visit 2.
Female
55 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00542984
6680, B3D-KL-GHCC
No
Not Provided
Eli Lilly and Company
Not Provided
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM-5PM Eastern time (UTC/GMY - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
October 2007

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