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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Original alendronate (Fosamax) | No Intervention | 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. | |
| Generic alendronate (Bonmax) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Generic alendronate | Drug | The patients will be given the generic alendronate 1 tablet per week for approximately 1 year after enrollment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year after treatment |
| Bone Resorption Markers (Serum CTX) |
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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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aasis Unnanuntana, MD | Mahidol University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Siriraj Hospital | Bangkok Noi | Bangkok | 10700 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28678853 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. Generic alendronate: The patients will be given the generic alendronate 1 tablet per week for approximately 1 year after enrollment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Generic Alendronate (Bonmax) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | percent | 1 year after treatment |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hip fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| myalgia and arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
small sample sizes and only one generic brand of bisphosphonate was used.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Aasis Unnanuntana | Mahidol University | +66836871159 | uaasis@gmail.com |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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|
Percent changes of serum bone markers (serum CTX) from baseline to 1-year after treatment will be compared and analysed between 2 groups.
| 1 year after treatment |
| Bone Formation Marker (Serum PINP) | 1 year after treatment |
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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | percent | 1 year after treatment |
|
|
|
| Secondary | 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. | Not Posted | Apr 2022 | 1 year after treatment | Participants |
| Secondary | Bone Formation Marker (Serum PINP) | Not Posted | Apr 2022 | 1 year after treatment | Participants |
| 1 |
| 70 |
| 16 |
| 70 |
| EG001 | 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. | 2 | 70 | 10 | 70 |
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| D009750 |
| Nutritional and Metabolic Diseases |