Osteoporosis Prevention With Low Dose Alendronate

University Hospital of Mont-Godinne

Status and phase: Completed; Phase 3

Conditions: Osteopenia

Treatments: Dietary Supplement: Calcium/Vitamin D; Drug: alendronate; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00463268

MG/OP 001

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy of the intermittent administration of alendronate in a low dose, 70 mg once every two week, as osteoporosis prevention for menopausal, osteopenic patients, who don't want or can't receive an oestrogenic substitution treatment.

Enrollment: 83 patients

Sex: Female

Ages: 45 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 45 to 60 year-old women
• Menopausal since at least 6 months
• Baseline lumbar BMD from -1 till -2.5

Exclusion criteria

• Bone disease other than osteopenia
• Treatment with selective estrogen receptor modulator (SERMs), calcitonin or hormone replacement therapy within 6 monts prior to randomization
• Former or current treatment with any bisphosphonate or bone forming agents
• Chronic use of oral or iv corticosteroids
• Any diagnosis of malignancy less than 12 months

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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83 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Alendronate 70 mg every 2 weeks

Treatment:

Dietary Supplement: Calcium/Vitamin D

Drug: alendronate

2

Placebo Comparator group

Description:

Alendronate 70 mg placebo tablet every 2 weeks

Treatment:

Drug: placebo

Dietary Supplement: Calcium/Vitamin D