A Study to Evaluate Oral Salmon Calcitonin in the Treatment of Osteoporosis in Postmenopausal Women Taking Calcium and Vitamin D
This study has been completed.
Sponsor:
Nordic Bioscience A/S
Collaborator:
Novartis
Information provided by (Responsible Party):
Nordic Bioscience A/S
ClinicalTrials.gov Identifier:
NCT00525798
First received: September 5, 2007
Last updated: October 22, 2012
Last verified: October 2012
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoporosis |
Drug: SMC021 Oral calcitonin Drug: SMC021 Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Multi-Center, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Salmon Calcitonin in the Treatment of Osteoporosis in Postmenopausal Women Taking Calcium and Vitamin D |
Resource links provided by NLM:
Further study details as provided by Nordic Bioscience A/S:
Primary Outcome Measures:
- Number of Patients With New Vertebral Fractures [ Time Frame: From baseline to month 36 ] [ Designated as safety issue: No ]
The primary variable was the occurrence or not of a new vertebral fracture during the 3 year observation period. New vertebral fractures were identified from an assessment of x-ray of the lateral spine through time (at baseline and at yearly intervals thereafter).
The outcome is the number of new vertebral fractures from baseline to 36 months.
Secondary Outcome Measures:
- Number of Patients With Non-vertebral Fractures [ Time Frame: From baseline to month 36 ] [ Designated as safety issue: No ]
The secondary outcome was the occurrence or not of a non-vertebral fracture during the 3 year observation period. Non-vertebral fractures of interest were: hip fractures, forearm fractures, humurus fractures, rib fractures and clavicular fractures.
Any new non-vertebral fractures while on-study were recorded. A copy of radiographs confirming the fracture, as well as a copy of the radiologist's report was to be obtained. A copy of the emergency room discharge letter or a hospital discharge letter was also obtained.
| Enrollment: | 4665 |
| Study Start Date: | March 2007 |
| Study Completion Date: | November 2011 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
SMC021 - Oral Calcitonin
|
Drug: SMC021 Oral calcitonin
0.8mg SMC021 - oral calcitonin, once daily
|
|
Placebo Comparator: SMC021- Placebo
SMC021 - placebo
|
Drug: SMC021 Placebo
SMC021 - Placebo, once daily
|
Eligibility| Ages Eligible for Study: | 55 Years to 85 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00525798
Locations
| United States, Georgia | |
| United Osteporosis Centers | |
| Gainesville, Georgia, United States, 30501 | |
| United States, Michigan | |
| Michigan Bone & Mineral Clinic PC, | |
| Detroit, Michigan, United States, 48236 | |
| United States, Oregon | |
| Oregon Osteoporosis Center | |
| Portland, Oregon, United States, 97213 | |
| Brazil | |
| CCBR Brazil | |
| Rio de Janeiro, Brazil, 22271-100 | |
| China | |
| CCBR China | |
| Beijing, China, 102206 | |
| Czech Republic | |
| CCBR Czech | |
| Pardubice, Czech Republic, 53002 | |
| Denmark | |
| CCBR Aalborg | |
| Aalborg, Denmark, 9000 | |
| CCBR Ballerup | |
| Ballerup, Denmark, 2750 | |
| CCBR Vejle | |
| Vejle, Denmark, 7100 | |
| Estonia | |
| CCBR Estonia | |
| Tallinn, Estonia, 10128 | |
| France | |
| Hopital Edouard Herriot | |
| Lyon, France, 69437 | |
| Hong Kong | |
| CCBR Hong Kong | |
| Hong Kong, Hong Kong | |
| Italy | |
| Department of Internal Medicine, University of Florence | |
| Florence, Italy | |
| Lithuania | |
| CCBR Lithuania | |
| Vilnius, Lithuania, 10323 | |
| Poland | |
| CCBR Poland | |
| Warsaw, Poland, 04703 | |
| Romania | |
| CCBR Romania | |
| Bucharest, Romania, 030463 | |
Sponsors and Collaborators
Nordic Bioscience A/S
Novartis
Investigators
| Study Chair: | Bente J Riis, M.D. | Nordic Bioscience A/S |
More Information
No publications provided by Nordic Bioscience A/S
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Nordic Bioscience A/S |
| ClinicalTrials.gov Identifier: | NCT00525798 History of Changes |
| Other Study ID Numbers: | SMC021A2303 |
| Study First Received: | September 5, 2007 |
| Results First Received: | September 14, 2012 |
| Last Updated: | October 22, 2012 |
| Health Authority: | Denmark: Danish Medicines Agency Estonia: The State Agency of Medicine Lithuania: State Medicine Control Agency - Ministry of Health Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Czech Republic: State Institute for Drug Control Romania: National Medicines Agency Brazil: Ministry of Health Hong Kong: Department of Health China: Ministry of Health France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Italy: Ministry of Health United States: Food and Drug Administration |
Keywords provided by Nordic Bioscience A/S:
|
Osteoporosis, oral salmon calcitonin, treatment, efficacy, tolerability |
Additional relevant MeSH terms:
|
Osteoporosis Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Salmon calcitonin Calcitonin Vitamin D Calcitonin Gene-Related Peptide Vitamins |
Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Vasodilator Agents Cardiovascular Agents Therapeutic Uses Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 23, 2013