Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Eli Lilly and Company |
---|---|
Information provided by: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT00239629 |
The aim of this study is to directly compare the bone forming effects of 20 microg/day of teriparatide with those of 2 g/day strontium ranelate as measured by the histomorphometric variables and biochemical bone formation markers after 6 months of therapy in postmenopausal women with osteoporosis.
Condition | Intervention | Phase |
---|---|---|
Postmenopausal Osteoporosis |
Drug: Teriparatide Drug: Strontium ranelate Procedure: Transiliac bone biopsy |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Differential Effects of Teriparatide and Strontium Ranelate on Bone Remodeling and Formation in Postmenopausal Women With Osteoporosis |
Estimated Enrollment: | 73 |
Study Start Date: | September 2005 |
Study Completion Date: | January 2007 |
Ages Eligible for Study: | 45 Years to 90 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
Normal or clinically insignificant abnormal laboratory values (as defined by the investigator) including serum calcium, PTH(1 84), alkaline phosphatase.
EXCLUSION CRITERIA:
Significantly impaired renal function as defined by either of the following criteria:
ClCr (mL/minute) = [[(140-age) x weight (kg)]x0.85] / [72 x serum Cr (mg/dL)]
Current or past treatment with any bisphosphonate, parathyroid hormone or its analogs, androgens or other anabolic steroids or therapeutic doses of fluorides at any time prior to Visit 2.
Past treatment (more than 12 months before Visit 2) with a selective estrogen receptor modulator (SERM), nasal or injectable calcitonin, oral, transdermal, or injectable estrogens, progestins, estrogen analogs, estrogen agonists, estrogen antagonists or tibolone is allowed. Previous or current use of fluoridated water or topical dental fluoride treatments are permitted.
Czech Republic | |
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. | |
Prague, Czech Republic, 128 21 | |
Germany | |
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. | |
Hamburg, Germany, 20354 | |
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. | |
Heidelberg, Germany, 69120 | |
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. | |
Magdeburg, Germany, D-39110 | |
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. | |
Vogelsang, Germany, 39245 | |
Greece | |
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. | |
Kifissia, Greece, 145 61 | |
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. | |
Thessaloniki, Greece, 56429 | |
Israel | |
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. | |
Haifa, Israel, 31096 | |
Mexico | |
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. | |
Guadalajara, Mexico, 44670 | |
Spain | |
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. | |
Barcelona, Spain, 08025 | |
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. | |
Madrid, Spain, 28041 |
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 |
Study ID Numbers: | 10080, B3D-EW-GHCX |
Study First Received: | October 13, 2005 |
Last Updated: | June 11, 2007 |
ClinicalTrials.gov Identifier: | NCT00239629 |
Health Authority: | Spain: Ministry of Health |
Musculoskeletal Diseases Teriparatide Osteoporosis, Postmenopausal Osteoporosis |
Bone Diseases, Metabolic Bone Diseases Strontium ranelate |
Physiological Effects of Drugs Bone Density Conservation Agents Pharmacologic Actions |