Osteoporosis
Conditions
Keywords
Osteoporosis, Bisphosphonates, Alendronate, Bone mineral density, Bone markers
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.
Interventions
DRUGGeneric alendronate
The patients will be given the generic alendronate 1 tablet per week for approximately 1 year after enrollment.
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
Thailand
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 70 |
| 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. | 70 |
| Total | 140 |
Baseline characteristics
| Characteristic | Original Alendronate (Fosamax) | Generic Alendronate (Bonmax) | Total |
|---|---|---|---|
| Age, Continuous | 73.7 years STANDARD_DEVIATION 9.7 | 73.7 years STANDARD_DEVIATION 7.2 | 73.7 years STANDARD_DEVIATION 8.6 |
| Sex: Female, Male Female | 66 Participants | 61 Participants | 127 Participants |
| Sex: Female, Male Male | 4 Participants | 9 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 16 / 70 | 10 / 70 |
| serious Total, serious adverse events | 1 / 70 | 2 / 70 |
Outcome results
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.
Time frame: 1 year after treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Original Alendronate (Fosamax) | Bone Mineral Density (BMD) at Lumbar Spine (L1-L4) | 5.54 percent | Standard Deviation 6.39 |
| Generic Alendronate (Bonmax) | Bone Mineral Density (BMD) at Lumbar Spine (L1-L4) | 5.39 percent | Standard Deviation 4.83 |
Secondary
Bone Formation Marker (Serum PINP)
Time frame: 1 year after treatment
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.
Time frame: 1 year after treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Original Alendronate (Fosamax) | Bone Mineral Density (BMD) at Total Hip | 2.48 percent | Standard Deviation 4.56 |
| Generic Alendronate (Bonmax) | Bone Mineral Density (BMD) at Total Hip | 2.52 percent | Standard Deviation 3.51 |
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.
Time frame: 1 year after treatment