Phase 3
Completed N=4,665
A Study to Evaluate Oral Salmon Calcitonin in the Treatment of Osteoporosis in Postmenopausal Women Taking Calcium and Vitamin D
Source: ClinicalTrials.gov NCT00525798 ↗Enrolled (actual)
4,665
Serious AEs
15.4%
Results posted
Oct 2012
Primary outcomePrimary: Number of Patients With New Vertebral Fractures — 94; 99 Participants
Summary
The purpose of this Phase III study is to evaluate the efficacy and safety of oral salmon calcitonin in the treatment of patients with osteoporosis
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With New Vertebral Fractures |
94; 99 | — |
| SECONDARY Number of Patients With Non-vertebral Fractures |
75; 82 | — |
Eligibility Criteria
Inclusion Criteria
- Postmenopausal women with osteoporosis, ambulatory, in general good health, not receiving medication that affects bone metabolism, and free from any underlying condition, other than osteoporosis, that may result in abnormal bone metabolism.
Exclusion Criteria
- BMD T-score below -4.0 (based on absolute values g/cm2 as given in the protocol) at one or more of the measured sites
- More than 2 prevalent vertebral fractures (Genant et al, 15).
- If BMD is lower than -2.5 T-score at one or more of the measured sites, the participants will be excluded from the study, if they have a severe vertebral fracture (Genant et al, 15).
- Evidence of any clinical osteoporotic fracture and/or if they have a history of a clinical osteoporotic fracture (excluding wrist fractures)
- BMD T-score > -1.5 in all of the following regions: Lumbar spine, femoral neck or total hip.
Other protocol defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT00525798). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.