A Study of Oral Recombinant Salmon Calcitonin (rsCT) to Prevent Postmenopausal 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: NCT01292187|
Recruitment Status : Completed
First Posted : February 9, 2011
Results First Posted : September 12, 2014
Last Update Posted : September 12, 2014
|Study Design||Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Prevention|
Drug: Oral calcitonin at dinnertime
Drug: Oral placebo at dinnertime
Drug: Oral calcitonin at bedtime
Drug: Oral placebo at bedtime
Subjects will be recruited from outpatient populations associated with health care centers that treat osteoporosis. Community advertising may also be used for those not associated with such centers.
Recruitment began on 17 January 2011.
|Pre-assignment Details||All patients had a two-week single-blind oral placebo (at bedtime) run-in period before group assignment. This was to accustom the patients to the oral dose regimen prior to randomization|