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A Study of the Treatment of Postmenopausal Women With Osteoporosis

Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteoporosis, Post-Menopausal

Intervention: teriparatide 20 micrograms/day subcutaneous (Drug); salmon calcitonin 100 IU/day subcutaneous (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
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), Study Director, Affiliation: Eli Lilly and Company

Summary

To compare the effect of treatment with teriparatide with that of salmon calcitonin in postmenopausal women with osteoporosis.

Clinical Details

Official title: Comparison of Teriparatide and Calcitonin in the Treatment of Postmenopausal Women With Osteoporosis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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.

Secondary outcome:

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.

Eligibility

Minimum age: 55 Years. Maximum age: 85 Years. Gender(s): Female.

Criteria:

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.

Locations and Contacts

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., Hong Kong, China

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., Shatin, China

Additional Information

Lilly Clinical Trial Registry

Starting date: June 2003
Last updated: October 10, 2007

Page last updated: August 23, 2015

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