Status:
COMPLETED
The Effect of Effervescent Alendronate on Bone Turnover
Lead Sponsor:
Aarhus University Hospital
Conditions:
Osteopenia or Osteoporosis
Eligibility:
FEMALE
Phase:
PHASE4
Brief 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 t...
Detailed Description
Alendronate is mainstay in the treatment of osteoporosis but is often discontinued due to gastro-intestinal side-effects. These side effects are believed to be caused by a low gastric pH induced by th...
Eligibility Criteria
Inclusion
- 2 years since last menstrual bleeding
- Bone mineral density T-score \< -1 at either lumbar spine or hip
- CTx \> 0.42 µg/L
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT05325515
Start Date
October 1 2021
End Date
December 1 2022
Last Update
February 8 2023
Active Locations (1)
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1
Aarhus University Hospital
Aarhus C, Central Jutland, Denmark, 8000