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 Study

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.

Study Overview

• Status: Completed
• Conditions: Osteopenia or Osteoporosis
• Intervention / Treatment: Drug: Conventional alendronate; Drug: Effervescent and buffered alendronate

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 the drug. Effervescent and buffered alendronate is a new formulation that increases gastric pH and thereby decreases risk of side effects but the clinical effect of the drug is not fully elucidated. In the present study 64 postmenopausal women with a bone mineral density T-score < -1 are randomized 1:1 to open label treatment with effervescent and buffered alendronate or conventional alendronate 70 mg weekly for 16 weeks. The primary end-point is change in the bone resorption marker "carboxy-terminal collagen crosslinks" from baseline to 16 weeks. The decrease in the two groups is compared using non-inferiority statistics. Secondary end-points include change in the bone formation marker "propeptide of type 1 procollagen", rate of change in the two bone markers and occurence of side effects.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Central Denmark Region
    • Aarhus C, Central Denmark Region, Denmark, 8000
      • Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Fosamax (conventional alendronate); Conventional alendronate 70mg weekly for 16 weeks	Drug: Conventional alendronate; Conventional alendronate 70mg weekly
EXPERIMENTAL: Binosto (effervescent and buffered alendronate); Effervescent and buffered alendronate70mg weekly for 16 weeks	Drug: Effervescent and buffered alendronate; Effervescent and buffered alendronate 70mg weekly

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CTx	Change in the bone resorption marker CTx	baseline to week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
P1NP	Change in the bone resorption marker P1NP	baseline to week 16

Collaborators and Investigators

• Sponsor: Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2021
• Primary Completion (ACTUAL): September 1, 2022
• Study Completion (ACTUAL): December 1, 2022

Study Registration Dates

• First Submitted: April 5, 2022
• First Submitted That Met QC Criteria: April 12, 2022
• First Posted (ACTUAL): April 13, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 4, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Osteoporosis; Bone Diseases, Metabolic; Physiological Effects of Drugs; Bone Density Conservation Agents; Alendronate
• Other Study ID Numbers: Binosto_1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No