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The Effect of Effervescent Alendronate on Bone Turnover

Primary Purpose

Osteopenia or Osteoporosis

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Conventional alendronate
Effervescent and buffered alendronate
Sponsored by
Aarhus University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteopenia or Osteoporosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Aarhus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Fosamax (conventional alendronate)

Binosto (effervescent and buffered alendronate)

Arm Description

Conventional alendronate 70mg weekly for 16 weeks

Effervescent and buffered alendronate70mg weekly for 16 weeks

Outcomes

Primary Outcome Measures

CTx
Change in the bone resorption marker CTx

Secondary Outcome Measures

P1NP
Change in the bone resorption marker P1NP

Full Information

First Posted
April 5, 2022
Last Updated
February 4, 2023
Sponsor
Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05325515
Brief Title
The Effect of Effervescent Alendronate on Bone Turnover
Official Title
The Effect of Effervescent and Buffered Alendronate on Bone Turnover Compared to Conventional Alendronate: A Randomized Non-inferiority Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
September 1, 2022 (Actual)
Study Completion Date
December 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aarhus University Hospital

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteopenia or Osteoporosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
2 study arms in which participants are allocated by randomization 1:1. Randomixation is performed in 8 blocks of 8.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fosamax (conventional alendronate)
Arm Type
Active Comparator
Arm Description
Conventional alendronate 70mg weekly for 16 weeks
Arm Title
Binosto (effervescent and buffered alendronate)
Arm Type
Experimental
Arm Description
Effervescent and buffered alendronate70mg weekly for 16 weeks
Intervention Type
Drug
Intervention Name(s)
Conventional alendronate
Intervention Description
Conventional alendronate 70mg weekly
Intervention Type
Drug
Intervention Name(s)
Effervescent and buffered alendronate
Intervention Description
Effervescent and buffered alendronate 70mg weekly
Primary Outcome Measure Information:
Title
CTx
Description
Change in the bone resorption marker CTx
Time Frame
baseline to week 16
Secondary Outcome Measure Information:
Title
P1NP
Description
Change in the bone resorption marker P1NP
Time Frame
baseline to week 16

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus C
State/Province
Central Denmark Region
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

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The Effect of Effervescent Alendronate on Bone Turnover

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