The Effect of Effervescent Alendronate on Bone Turnover

• Status: Active, not recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

64 postmenopausal women are randomized to treatment with either effervescent and buffered alendronate or conventional alendronate -both 70mg weekly for 16 weeks to see if bone turnover is suppressed to the same extent as in the conventional formulation with the effervescent form.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aarhus University Hospital
• Treatments: Alendronate

Criteria

Inclusion Criteria:

• 2 years since last menstrual bleeding

• Bone mineral density T-score < -1 at either lumbar spine or hip

• CTx > 0.42 µg/L

Exclusion Criteria:

• Ever treatment for osteoporosis

• Indication for teriparatide treatment

• Treatment with oral systemic glucocorticoids within last 12 months

• Rheumatoid arthritis

• Inflammatory bowel disease

• Untreated thyroid disease

• Primary hyperparathyroidism

• Diabetes mellitus

• eGFR < 60 mL/min

• Cancer within last 2 years except basal cell carcinoma of the skin

• Hormone therapy

• Unstable liver disease

• Contraindications for alendronate

• Major gastrointestinal disease within 12 months (eg. esophagitis, ulcer, major surgery).

• Vitamin D < 50nmol/L