Efficacy and Safety of Brand Versus Generic Alendronate for Osteoporosis Treatment
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Original alendronate (Fosamax) 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. |
|
| Active Comparator: Generic alendronate (Bonmax) 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. |
Drug: Generic alendronate
The patients will be given the generic alendronate 1 tablet per week for approximately 1 year after enrollment.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Bone Mineral Density (BMD) at Lumbar Spine (L1-L4) [1 year after treatment]
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 [1 year after treatment]
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) [1 year after treatment]
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) [1 year after treatment]
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Siriraj Hospital | Bangkok Noi | Bangkok | Thailand | 10700 |
Sponsors and Collaborators
- Mahidol University
Investigators
- Principal Investigator: Aasis Unnanuntana, MD, Mahidol University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 150/2557(EC3)
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Original Alendronate (Fosamax) | Generic Alendronate (Bonmax) |
|---|---|---|
| Arm/Group 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. Generic alendronate: The patients will be given the generic alendronate 1 tablet per week for approximately 1 year after enrollment. |
| Period Title: Overall Study | ||
| STARTED | 70 | 70 |
| COMPLETED | 70 | 70 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Original Alendronate (Fosamax) | Generic Alendronate (Bonmax) | Total |
|---|---|---|---|
| Arm/Group 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. Generic alendronate: The patients will be given the generic alendronate 1 tablet per week for approximately 1 year after enrollment. | Total of all reporting groups |
| Overall Participants | 70 | 70 | 140 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
73.7
(9.7)
|
73.7
(7.2)
|
73.7
(8.6)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
66
94.3%
|
61
87.1%
|
127
90.7%
|
| Male |
4
5.7%
|
9
12.9%
|
13
9.3%
|
Outcome Measures
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Original Alendronate (Fosamax) | Generic Alendronate (Bonmax) |
|---|---|---|
| Arm/Group 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. Generic alendronate: The patients will be given the generic alendronate 1 tablet per week for approximately 1 year after enrollment. |
| Measure Participants | 70 | 70 |
| Mean (Standard Deviation) [percent] |
5.54
(6.39)
|
5.39
(4.83)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Original Alendronate (Fosamax) | Generic Alendronate (Bonmax) |
|---|---|---|
| Arm/Group 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. Generic alendronate: The patients will be given the generic alendronate 1 tablet per week for approximately 1 year after enrollment. |
| Measure Participants | 70 | 70 |
| Mean (Standard Deviation) [percent] |
2.48
(4.56)
|
2.52
(3.51)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Bone Formation Marker (Serum PINP) |
|---|---|
| Description | |
| Time Frame | 1 year after treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Original Alendronate (Fosamax) | Generic Alendronate (Bonmax) | ||
| Arm/Group 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. | ||
All Cause Mortality |
||||
| Original Alendronate (Fosamax) | Generic Alendronate (Bonmax) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Original Alendronate (Fosamax) | Generic Alendronate (Bonmax) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/70 (1.4%) | 2/70 (2.9%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| hip fracture | 1/70 (1.4%) | 70 | 2/70 (2.9%) | 70 |
Other (Not Including Serious) Adverse Events |
||||
| Original Alendronate (Fosamax) | Generic Alendronate (Bonmax) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 16/70 (22.9%) | 10/70 (14.3%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| myalgia and arthralgia | 16/70 (22.9%) | 10/70 (14.3%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Aasis Unnanuntana |
|---|---|
| Organization | Mahidol University |
| Phone | +66836871159 |
| uaasis@gmail.com |
- 150/2557(EC3)