Osteoporosis, Postmenopausal
Conditions
Brief summary
The purpose of this study is to see how well alendronate and calcium as compared to calcium alone increase bone density in postmenopausal women with osteoporosis
Interventions
DRUGMK0217, alendronate sodium / Duration of Treatment : 2 Years
DRUGComparator : calcium carbonate /Duration of Treatment : 2 Years
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
: * Patient is postmenopausal (or surgically menopausal) for at least 5 years. * Patient must be diagnosed with osteoporosis * Patient has spinal anatomy suitable for DEXA of the lumbar spine
Exclusion criteria
: * Patient is receiving or has received treatment prior to randomization which might influence bone turnover * Patient has a history of or evidence for metabolic bone disease (other than postmenopausal bone loss) * Patient is receiving or is expected to receive during the course of the study any medication (other than study medication) which might alter bone or calcium metabolism
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BMD of the lumbar spine determined by a DEXA scan at 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| BMD of the hip trochanter and femoral neck determined by a DEXA scan and biomarkers of bone turnover (BAP, NTX) at 2 years | — |
Outcome results
None listed