Clinical trial NCT00525798: A Study to Evaluate Oral Salmon Calcitonin in the Treatment of Osteoporosis in Postmenopausal Women Taking Calcium and Vitamin D
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoporosis
Keywords: Osteoporosis, oral salmon calcitonin, treatment, efficacy, tolerability
Lead sponsor: Nordic Bioscience A/S
Sponsor class: INDUSTRY
Collaborators: name: Novartis
First posted: 2007-09-06
Enrollment: 4665
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


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

Primary outcomes:
measure: Number of Patients With New Vertebral Fractures
timeFrame: From baseline to month 36
Secondary outcomes:
measure: Number of Patients With Non-vertebral Fractures
timeFrame: From baseline to month 36
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: United Osteporosis Centers
state: Georgia
city: Detroit
country: United States
facility: Michigan Bone & Mineral Clinic PC,
state: Michigan
city: Portland
country: United States
facility: Oregon Osteoporosis Center
state: Oregon
city: Rio de Janeiro
country: Brazil
facility: CCBR Brazil
city: Beijing
country: China
facility: CCBR China
city: Pardubice
country: Czech Republic
facility: CCBR Czech
city: Aalborg
country: Denmark
facility: CCBR Aalborg
city: Ballerup
country: Denmark
facility: CCBR Ballerup
city: Vejle
country: Denmark
facility: CCBR Vejle
city: Tallinn
country: Estonia
facility: CCBR Estonia
city: Lyon
country: France
facility: Hopital Edouard Herriot
city: Hong Kong
country: Hong Kong
facility: CCBR Hong Kong
city: Florence
country: Italy
facility: Department of Internal Medicine, University of Florence
city: Vilnius
country: Lithuania
facility: CCBR Lithuania
city: Warsaw
country: Poland
facility: CCBR Poland
city: Bucharest
country: Romania
facility: CCBR Romania
Study officials:
affiliation: Nordic Bioscience A/S
name: Bente J Riis, M.D.
role: STUDY_CHAIR
References:
citation: Henriksen K, Bay-Jensen AC, Christiansen C, Karsdal MA. Oral salmon calcitonin--pharmacology in osteoporosis. Expert Opin Biol Ther. 2010 Nov;10(11):1617-29. doi: 10.1517/14712598.2010.526104. Epub 2010 Oct 11.