The Effect of Effervescent Alendronate on Bone Turnover

NCT05325515 | Completed Phase 4 DMC

• 1 other identifier: Binosto_1
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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 to the same extent as in the conventional formulation with the effervescent form.

Conditions

Osteopenia or Osteoporosis

Outcome Measures

Primary Outcomes (1)

• CTx

  Change in the bone resorption marker CTx

  baseline to week 16

Secondary Outcomes (1)

• P1NP

  baseline to week 16

Study Arms (2)

Fosamax (conventional alendronate)

ACTIVE COMPARATOR

Conventional alendronate 70mg weekly for 16 weeks

Drug: Conventional alendronate

Binosto (effervescent and buffered alendronate)

EXPERIMENTAL

Effervescent and buffered alendronate70mg weekly for 16 weeks

Drug: Effervescent and buffered alendronate

Interventions

Conventional alendronate DRUG

Conventional alendronate 70mg weekly

Fosamax (conventional alendronate)

Effervescent and buffered alendronate DRUG

Effervescent and buffered alendronate 70mg weekly

Binosto (effervescent and buffered alendronate)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• years since last menstrual bleeding
• Bone mineral density T-score \< -1 at either lumbar spine or hip
• CTx \> 0.42 µg/L

You may not qualify if:

• 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

Sponsors & Collaborators

• Aarhus University Hospital: lead

Study Sites (1)

Aarhus University Hospital

Aarhus C, Central Jutland, 8000, Denmark

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic; Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, consultant in endocrinology

Model Details: 2 study arms in which participants are allocated by randomization 1:1. Randomixation is performed in 8 blocks of 8.

Study Record Dates

• First Submitted: April 5, 2022
• First Posted: April 13, 2022
• Study Start: October 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: December 1, 2022
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

DK (1)