The Effect of Effervescent Alendronate on Bone Turnover

Sponsor

Aarhus University Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05325515

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteopenia or Osteoporosis	Drug: Conventional alendronate Drug: Effervescent and buffered alendronate	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

64 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

2 study arms in which participants are allocated by randomization 1:1. Randomixation is performed in 8 blocks of 8.2 study arms in which participants are allocated by randomization 1:1. Randomixation is performed in 8 blocks of 8.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Effect of Effervescent and Buffered Alendronate on Bone Turnover Compared to Conventional Alendronate: A Randomized Non-inferiority Study

Actual Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

CTx [baseline to week 16]
Change in the bone resorption marker CTx

Secondary Outcome Measures

P1NP [baseline to week 16]
Change in the bone resorption marker P1NP

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aarhus University Hospital	Aarhus C	Central Denmark Region	Denmark	8000

Sponsors and Collaborators

Aarhus University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Torben Harsløf, MD, PhD, consultant in endocrinology, Aarhus University Hospital

ClinicalTrials.gov Identifier:

NCT05325515

Other Study ID Numbers:

Binosto_1

First Posted:

Apr 13, 2022

Last Update Posted:

Apr 13, 2022

Last Verified:

Apr 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Osteoporosis

Bone Diseases, Metabolic

Alendronate

Study Results

No Results Posted as of Apr 13, 2022