The effect of effervescent alendronate on bone turnover

Phase 1

• Conditions: Osteopenia, i.e. bone mineral density T-score < -1; MedDRA version: 20.0Level: LLTClassification code 10005991Term: Bone mass decreasedSystem Organ Class: 100000004848; Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]

• Registration Number: EUCTR2020-005040-35-DK
• Lead Sponsor: Aarhus University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-03
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 64

Inclusion Criteria

Sixty-four postmenopausal women with BMD T-score < -1 osteopenia and high bone turnover.
-2 years since last menstrual bleeding
-Bone mineral density T-score < -1 at either lumbar spine or hip
-CTx > 0.42 µg/L

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 34

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate if Binosto decreases bone resorption to the same extent as Fosamax;Secondary Objective: To investigate:<br>- If Binosto decreases bone turnoverformation to the same extent as Fosamax<br>- The rate of decrease in bone turnover between the two IMPs<br>- Difference in AEs between the two IMPs;Primary end point(s): -Percent change in CTx from baseline to end of study;Timepoint(s) of evaluation of this end point: After 16 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: After 16 weeks;Secondary end point(s): -Percent change in P1NP from baseline to end of study<br>-Differences in rate of decline of CTx and P1NP between treatment groups<br>-Adverse events (AEs)<br>-Serious adverse events (SAEs)<br>-Persistence (tablet count)<br>