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Sponsored by: |
Nycomed |
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Information provided by: | Nycomed |
ClinicalTrials.gov Identifier: | NCT00479037 |
The primary objective of this trial is to show that PTH(1-84) is superior to strontium ranelate in bone formation measured as changes in bone formation markers over a treatment period of 24 weeks in postmenopausal women with primary osteoporosis.
Condition | Intervention | Phase |
---|---|---|
Osteoporosis |
Drug: Parathyronine hormone (PTH) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A 24-Week, International, Multi Centre, Randomised, Open Label, Parallel Group, Phase IV Clinical Trial Investigating Changes in Bone Formation Markers in Postmenopausal Women With Primary Osteoporosis Treated With Either PTH(1-84) or Strontium Ranelate |
Estimated Enrollment: | 70 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Postmenopausal women at or above the age of 50, diagnosed with primary osteoporosis may be enrolled in the trial if the following inclusion/exclusion criteria apply. All inclusion criteria must be answered "yes" for a subject to be enrolled in the trial.
Exclusion criteria:
All exclusion criteria must be answered "no" for a subject to be enrolled in the trial.
Has the subject:
received or is the subject currently receiving chronic glucocorticosteroid treatment?
Defined as more or equal to:
5.0mg prednisolon or equivalent daily for 3 months during the last year or 2.5mg prednisolon or equivalent daily for 6 months during the last year. Local and inhalation steroids are permitted.
2Note that exclusion criteria no. 16 to 21 can not be evaluated before the result of the blood sampling (planned within the screening period and after at least 14 days of supplemental calcium/vitamin D3 intake) is available. See details in section 8.2.1
Contact: Nycomed Clinical Trial Operations | +45 4677 1111 | clinicaltrials@nycomed.com |
Denmark | |
Nycomed | Recruiting |
Roskilde, Denmark, 4000 | |
Contact: Clinical Trial Operations clinicaltrials@nycomed.com |
Study Chair: | Nycomed Clinical Trial Operations | Headquaters |
Responsible Party: | Nycomed ( Nycomed ) |
Study ID Numbers: | FP-006-IM, 2006-006065-16 |
Study First Received: | May 23, 2007 |
Last Updated: | January 19, 2009 |
ClinicalTrials.gov Identifier: | NCT00479037 History of Changes |
Health Authority: | Austria: Ethikkommission; Spain: Spanish Agency of Medicines |
postmenopausal women with primary osteoporosis |
Musculoskeletal Diseases Osteoporosis Bone Density Conservation Agents Bone Diseases, Metabolic |
Hormones Bone Diseases Strontium ranelate |
Musculoskeletal Diseases Physiological Effects of Drugs Osteoporosis Bone Density Conservation Agents |
Bone Diseases, Metabolic Bone Diseases Pharmacologic Actions Strontium ranelate |