The effect of effervescent alendronate on bone turnover

The effect of effervescent and buffered alendronate on bone turnover compared to conventional alendronate: A randomized non-inferiority trial

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-005040-35-DK

Enrollment

Registered

2020-12-03

Start date

2021-01-28

Completion date

Unknown

Last updated

2021-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteopenia, i.e. bone mineral density T-score < -1 MedDRA version: 20.0 Level: LLT Classification code 10005991 Term: Bone mass decreased System Organ Class: 100000004848

Interventions

Trade Name: Binosto Pharmaceutical Form: Effervescent tablet INN or Proposed INN: Alendronate Other descriptive name: ALENDRONATE SODIUM TRIHYDRATE Concentration unit: mg milligram(s) Concentration ty

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Sixty-four postmenopausal women with BMD T-score 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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate if Binosto decreases bone resorption to the same extent as Fosamax;Secondary Objective: To investigate: - If Binosto decreases bone turnoverformation to the same extent as Fosamax - The rate of decrease in bone turnover between the two IMPs - 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	—

Measure

Time frame

Main Objective: To investigate if Binosto decreases bone resorption to the same extent as Fosamax;Secondary Objective: To investigate: - If Binosto decreases bone turnoverformation to the same extent as Fosamax - The rate of decrease in bone turnover between the two IMPs - 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

Measure	Time frame
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 - Differences in rate of decline of CTx and P1NP between treatment groups - Adverse events (AEs) - Serious adverse events (SAEs) - Persistence (tablet count)	—

Countries

Denmark

Contacts

Public ContactDept. of Endocrinology

Aarhus University Hospital

bentlang@rm.dk004578455470

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026