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Efficacy and Safety of Brand Versus Generic Alendronate for Osteoporosis Treatment

Primary Purpose

Osteoporosis

Status

Completed

Phase

Phase 4

Locations

Thailand

Study Type

Interventional

Intervention

Generic alendronate

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring Osteoporosis, Bisphosphonates, Alendronate, Bone mineral density, Bone markers

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

History of spinal or hip fractures with low energy trauma.
BMD by Dual energy X-ray absorptiometry (DXA) scan with T-score ≤ -2.5 at the femoral neck, total hip, or L1-L4 spine.
BMD by DXA scan with T-score between -1 and -2.5 at the femoral neck, total hip, or L1-L4 spine and a 10-year hip fracture probability ≥ 3% or a 10-year major osteoporosis-related fracture probability ≥ 20% based on Fracture risk assessment tool (FRAX)

Exclusion Criteria:

Patients who have contraindications to use bisphosphonates e.g. gastroesophageal reflux disease or drug allergy to bisphosphonates
Patients with an abnormality of serum calcium levels (more than 10.2 mg/dl or less than 8.7 mg/dl)
Patients with estimated glomerular filtration rate less than 30 mL/min/1.73 m2
Patients with metabolic bone diseases such as Paget's disease, hyperparathyroidism, etc.
Patients who were received anti-osteoporotic drugs during the past 1 year.
Patients who currently taking steroids, hormone replacement therapy, or selective estrogen receptor modulators (SERMs) within 1 year.

Sites / Locations

Siriraj Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Original alendronate (Fosamax)

Generic alendronate (Bonmax)

Arm Description

The patients will be given the brand alendronate (Fosamax®) (70 mg) 1 tablet once a week orally for 1 year after enrollment. In addition, calcium and vitamin D supplementation will be given to all patients.

The patients will be given the generic alendronate (Bonmax®) (70 mg) 1 tablet once a week orally for 1 year after enrollment. In addition, calcium and vitamin D supplementation will be given to all patients.

Outcomes

Primary Outcome Measures

Bone Mineral Density (BMD) at Lumbar Spine (L1-L4)

Percent changes of bone mineral density at lumbar spine (L1-L4) from baseline to 1-year after treatment will be compared and analysed between 2 groups.

Secondary Outcome Measures

Bone Mineral Density (BMD) at Total Hip

Percent changes of bone mineral density at total hip from baseline to 1-year after treatment will be compared and analysed between 2 groups.

Bone Resorption Markers (Serum CTX)

Percent changes of serum bone markers (serum CTX) from baseline to 1-year after treatment will be compared and analysed between 2 groups.

Bone Formation Marker (Serum PINP)

Full Information

NCT ID

NCT02371252

First Posted

September 7, 2014

Last Updated

September 1, 2021

Sponsor

Mahidol University

1. Study Identification

Unique Protocol Identification Number

NCT02371252

Brief Title

Efficacy and Safety of Brand Versus Generic Alendronate for Osteoporosis Treatment

Official Title

Randomized Trial Comparing Efficacy and Safety of Brand Versus Generic Alendronate for Osteoporosis Treatment

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

April 2014 (undefined)

Primary Completion Date

December 2016 (Actual)

Study Completion Date

December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mahidol University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Osteoporosis is a common disease defined as a decrease in bone mass and strength which increases risk of fragility fractures. This disorder may affecting health in many adults which causing disability, morbidity, and mortality. Current first-line medical therapy is bisphosphonates which alendronate is one of the most widely used. However, expenditure on medicines is one of the major problem of inadequate access to treatment. The investigators hypothesized that generic alendronate will have the same clinical efficacy as the brand formulation. Therefore, the result of this study is extremely crucial. If adequate efficacy of generic alendronate could be established and if it affords the same safety profile as those of brand alendronate, the use of generic alendronate could then be recommended.

Detailed Description

Osteoporosis is a common disease which estimated that over 200 million people worldwide are suffered. The prevalence is continuing to escalate with the increasingly elderly population. The risk of fragility fractures in elder over age 50 is approximately 50% in women and 20% in men. Current first-line medical therapy is bisphosphonates which alendronate is one of the most widely used. However, expenditure on medicines is one of the major problem of inadequate access to treatment. Generally, insurances and health care providers prefer physicians to prescribe generic instead of brand drug, due to its lower costs. However, clinical information on bone mineral density (BMD), fracture reduction and side effects with new generic alendronate is limited. The objective of this study is to evaluate the efficacy and safety of a new generic alendronate (Bonmax®) comparing to brand alendronate (Fosamax®). The efficacy of generic alendronate will be determined by measuring the percent changes of bone mineral densities at lumbar spine and total hip after 1 year of treatment and then comparing to those changes in the brand alendronate group.

6. Conditions and Keywords

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

Osteoporosis

Keywords

Osteoporosis, Bisphosphonates, Alendronate, Bone mineral density, Bone markers

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

140 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Original alendronate (Fosamax)

Arm Type

No Intervention

Arm Description

Arm Title

Generic alendronate (Bonmax)

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Generic alendronate

Other Intervention Name(s)

Bonmax

Intervention Description

The patients will be given the generic alendronate 1 tablet per week for approximately 1 year after enrollment.

Primary Outcome Measure Information:

Title

Bone Mineral Density (BMD) at Lumbar Spine (L1-L4)

Description

Percent changes of bone mineral density at lumbar spine (L1-L4) from baseline to 1-year after treatment will be compared and analysed between 2 groups.

Time Frame

1 year after treatment

Secondary Outcome Measure Information:

Title

Bone Mineral Density (BMD) at Total Hip

Description

Percent changes of bone mineral density at total hip from baseline to 1-year after treatment will be compared and analysed between 2 groups.

Time Frame

1 year after treatment

Title

Bone Resorption Markers (Serum CTX)

Description

Percent changes of serum bone markers (serum CTX) from baseline to 1-year after treatment will be compared and analysed between 2 groups.

Time Frame

1 year after treatment

Title

Bone Formation Marker (Serum PINP)

Time Frame

1 year after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: patients who are postmenopausal women or men who aged older than 50 years and meet the indications for osteoporosis treatment according to the Thai Osteoporosis Foundation's 2010 treatment guidelines. History of spinal or hip fractures with low energy trauma. BMD by Dual energy X-ray absorptiometry (DXA) scan with T-score ≤ -2.5 at the femoral neck, total hip, or L1-L4 spine. BMD by DXA scan with T-score between -1 and -2.5 at the femoral neck, total hip, or L1-L4 spine and a 10-year hip fracture probability ≥ 3% or a 10-year major osteoporosis-related fracture probability ≥ 20% based on Fracture risk assessment tool (FRAX) Exclusion Criteria: Patients who have contraindications to use bisphosphonates e.g. gastroesophageal reflux disease or drug allergy to bisphosphonates Patients with an abnormality of serum calcium levels (more than 10.2 mg/dl or less than 8.7 mg/dl) Patients with estimated glomerular filtration rate less than 30 mL/min/1.73 m2 Patients with metabolic bone diseases such as Paget's disease, hyperparathyroidism, etc. Patients who were received anti-osteoporotic drugs during the past 1 year. Patients who currently taking steroids, hormone replacement therapy, or selective estrogen receptor modulators (SERMs) within 1 year.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Aasis Unnanuntana, MD

Organizational Affiliation

Mahidol University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Siriraj Hospital

City

Bangkok Noi

State/Province

Bangkok

ZIP/Postal Code

10700

Country

Thailand

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

28678853

Citation

Unnanuntana A, Jarusriwanna A, Songcharoen P. Randomized clinical trial comparing efficacy and safety of brand versus generic alendronate (Bonmax(R)) for osteoporosis treatment. PLoS One. 2017 Jul 5;12(7):e0180325. doi: 10.1371/journal.pone.0180325. eCollection 2017.

Results Reference

derived

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Efficacy and Safety of Brand Versus Generic Alendronate for Osteoporosis Treatment

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