Overview

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