A Multicenter, Randomized Placebo Controlled Pilot MicroCT Study to Estimate the Effect of Treatment With Denosumab (AMG 162) and Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Density
Summary
This study is structured to estimate the effect of denosumab, compared to placebo and alendronate, on several bone parameters.
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Postmenopausal Osteoporosis
Intervention
Alendronate, Denosumab
Location
Research Site
San Francisco
California
United States
Status
Completed
Source
Amgen
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00293813
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Alendronate
A nonhormonal medication for the treatment of postmenopausal osteoporosis in women. This drug builds healthy bone, restoring some of the bone loss as a result of osteoporosis.
Osteoporosis
Reduction of bone mass without alteration in the composition of bone, leading to fractures. Primary osteoporosis can be of two major types: postmenopausal osteoporosis (OSTEOPOROSIS, POSTMENOPAUSAL) and age-related or senile osteoporosis.
Osteoporosis, Postmenopausal
Metabolic disorder associated with fractures of the femoral neck, vertebrae, and distal forearm. It occurs commonly in women within 15-20 years after menopause, and is caused by factors associated with menopause including estrogen deficiency.
Raloxifene
A second generation selective estrogen receptor modulator (SERM) used to prevent osteoporosis in postmenopausal women. It has estrogen agonist effects on bone and cholesterol metabolism but behaves as a complete estrogen antagonist on mammary gland and uterine tissue.
Estrogen Replacement Therapy
The use of hormonal agents with estrogen-like activity in postmenopausal or other estrogen-deficient women to alleviate effects of hormone deficiency, such as vasomotor symptoms, DYSPAREUNIA, and progressive development of OSTEOPOROSIS. This may also include the use of progestational agents in combination therapy.
Clinical Trials
Study of Transitioning From Alendronate to Denosumab
The study will evaluate the efficacy and safety of transitioning postmenopausal women on current alendronate therapy to denosumab. Endpoints studied will include bone mineral density, bon...
The purpose of this study is to determine whether in postmenopausal women with low bone mineral density, the mean percent change in total hip BMD in subjects receiving denosumab is not les...
Evaluate the efficacy and safety of denosumab in the treatment of involutional (postmenopausal and senile) osteoporotic subjects with prevalent fragility vertebral fracture(s)
The purpose of this study is to determine if denosumab is effective in increasing bone mineral density at the lumbar spine in Indian postmenopausal women with osteoporosis.
Denosumab Adherence Preference Satisfaction Study
The primary objective is to evaluate the adherence of subjects to SC 60 mg denosumab Q6M treatment compared to oral 70 mg alendronate QW treatment at the end of treatment period 1 (12 mont...
PubMed Articles
Adherence, preference, and satisfaction of postmenopausal women taking denosumab or alendronate.
In this study, 250 women with osteoporosis were randomized to 12 months with subcutaneous denosumab 60 mg every 6 months or oral alendronate 70 mg once weekly, then crossed over to the other treat...
Update on denosumab in postmenopausal osteoporosis-recent clinical data.
Denosumab, a fully human monoclonal antibody against the key osteoclastogenic factor RANK ligand, is currently approved for the treatment of postmenopausal osteoporosis. Denosumab differs from bisphos...
In a phase 2 study, continued denosumab treatment for up to 8 years was associated with continued gains in bone mineral density and persistent reductions in bone turnover markers. Denosumab treatment...
BACKGROUND: Osteoporosis, a skeletal disorder that adversely affects bone strength , is common among postmenopausal women primarily due to reduced ovarian estrogens....
Cost-effectiveness of denosumab in the treatment of postmenopausal osteoporosis in Canada.
Abstract OBJECTIVE: Denosumab is a novel biologic agent approved in Canada for treatment of postmenopausal osteoporosis (PMO) in women at high risk for fracture or who have failed or are intolerant to...
