Generic medicines are often used in public hospitals. However, data on the quality of generic alendronate, its efficacy, side-effects and medication adherence in clinical practice is scarce. Therefore, this study aimed to compare the side-effects and medication adherence of generic (apo-alendronate*) and proprietary alendronate (Fosamax†).
Matched MeSH terms: Bone Density Conservation Agents/adverse effects
Antiresorptive agents have been used as primary or first-line therapy in managing patients with osteoporosis. Bisphosphonates in particular are used widely to reduce bone resorption, increase bone mineral density, improve bone quality and therefore reduce fracture risk. However, prolonged use of bisphosphonates may cause over-suppression of bone resorption, leading on to accumulation of micro-damage in bone. This in turn might lead on to atypical femoral fractures. A patient treated with alendronate sodium for 8 years, and presenting with bilateral atypical femoral diaphyseal fractures is reported. X-rays of both femurs showed typical horizontal fracture line involving the thick lateral cortex with short oblique fracture pattern over the medial cortex. This fracture pattern was further confirmed with intra-operative examination of the fracture ends. Histopathological examination of the endocortical fragment removed from the proximal fracture end showed absence of osteoclasts and osteoblasts. Bone mineral density with dual energy X-ray absorptiometry (DXA) scan showed osteopenia over the femoral neck. Blood investigations did not show significant abnormalities. Bone turnover marker levels were not reliable, as presence of fracture might have altered the marker levels. Both femoral fractures united well. The patient reported here had complete pictures on X-ray examination, intra-operative findings, histopathological examination, DXA, as well as blood test results. Complete data should be collected from patients treated with alendronate sodium presenting with atypical femoral fractures to show any link between the use of alendronate sodium with atypical fracture of femur.
Matched MeSH terms: Bone Density Conservation Agents/adverse effects*
Strontium ranelate is a new effective anti-osteoporotic treatment having a unique mode of action, reducing bone resorption while promoting continued bone formation, with a broad range of anti-fracture efficacy at vertebral as well as peripheral sites. In Phase III studies, it has proven its early and sustained efficacy against vertebral fractures in Caucasians along with a significant increase in lumbar bone mineral density (BMD). The aim of this randomized double-blind study was to demonstrate the efficacy of strontium ranelate (2 g/day) on lumbar spine bone mineral density and the clinical and biological safety in Asian postmenopausal osteoporotic patients compared to placebo over 1 year. Three hundred and twenty-nine eligible women from mainland China, Hong Kong and Malaysia were randomized into the study. The baseline characteristics were similar in the treatment and placebo groups: mean age of 66.2+/-6.5 years, time since menopause 17.6+/-7.2 years. In the Full Analysis Set (FAS, N=302), the mean baseline lumbar L2-L4 BMD was 0.715+/-0.106 g/cm(2) in the strontium ranelate group and 0.708 +/- 0.109 g/cm2 in the placebo group. The mean baseline femoral neck BMD was 0.575+/-0.074 g/cm2 and 0.566+/-0.069 g/cm2 respectively and mean total hip BMD was 0.642+/-0.080 g/cm2 and 0.631 +/-0.088 g/cm2 respectively. The overall compliance was 91.4% in the study drug group, and 97.4% in the placebo group. After 1 year of treatment, the lumbar spine, femoral neck and total hip BMD in the treated group was significantly increased by 3-5% as compared to placebo. Strontium ranelate was well tolerated. The most frequently reported emergent adverse events were comparable in both groups (60.4% versus 60.0%), with majority of them being mild gastrointestinal disorders. There were no clinically relevant changes in laboratory tests, such as blood routine, hepatic and renal function. It is thus concluded that the effects of 2 g/day strontium ranelate on BMD and its safety profile in this cohort of postmenopausal osteoporotic Asian women were consistent with results obtained from Caucasian women in which the efficacy on the reduction in risk of fracture has been proven.
Matched MeSH terms: Bone Density Conservation Agents/adverse effects
BACKGROUND: This study describes the analysis of secondary outcomes from a previously published randomised controlled trial, which assessed the effects of pharmaceutical care on medication adherence, persistence and bone turnover markers. The main focus of this manuscript is the effect of the provision of pharmaceutical care on these secondary outcomes, and details on the design of the intervention provided, the osteoporosis care plan and materials used to deliver the intervention.
OBJECTIVES: To evaluate the effects of pharmaceutical care on knowledge, quality of life (QOL) and satisfaction of postmenopausal osteoporotic women prescribed bisphosphonates, and their associating factors.
SETTING: Randomised controlled trial, performed at an osteoporosis clinic of a tertiary hospital in Malaysia.
METHODS: Postmenopausal women diagnosed with osteoporosis (T-score ≤-2.5/lowtrauma fracture), just been prescribed weekly alendronate/risedronate were randomly allocated to receive intervention or standard care (controls). Intervention participants received a medication review, education on osteoporosis, risk factors, lifestyle modifications, goals of therapy, side effects and the importance of medication adherence at months 0, 3, 6 and 12.
MAIN OUTCOMES MEASURE: Knowledge, QOL and satisfaction.
RESULTS: A total of 198 postmenopausal osteoporotic women were recruited: intervention = 100 and control = 98. Intervention participants reported significantly higher knowledge scores at months 3 (72.50 vs. 62.50 %), 6 (75.00 vs. 65.00 %) and 12 (78.75 vs. 68.75 %) compared to control participants. QOL scores were also lower (which indicates better QOL) at months 3 (29.33 vs. 38.41), 6 (27.50 vs. 36.56) and 12 (27.53 vs. 37.56) compared to control participants. Similarly, satisfaction score was higher in intervention participants (93.67 vs. 84.83 %). More educated women, with back pain, who were provided pharmaceutical care had better knowledge levels. Similarly, older, more educated women, with previous falls and back pain tend to have poorer QOL, whilst women who exercised more frequently and were provided pharmaceutical care had better QOL. Satisfaction also increased as QOL increases and when provided pharmaceutical care.
CONCLUSION: The provision of pharmaceutical care improved knowledge, QOL and satisfaction in Malaysian postmenopausal osteoporotic women, showing that pharmacists have the potential to improve patients' overall bone health. Policymakers should consider placing a clinical pharmacist in the osteoporosis clinic to provide counselling to improve these outcomes.
Study site: Osteoporosis clinics, University Malaya Medical Centre (UMMC), Kuala Lumpur, Malaysia
Matched MeSH terms: Bone Density Conservation Agents/adverse effects
Pharmacists have been involved in providing comprehensive interventions to osteoporosis patients, but pharmaceutical care issues (PCIs) encountered during such interventions have not been well documented. Therefore, the aim of this study was to document PCIs encountered by post-menopausal osteoporotic women prescribed bisphosphonates.
Matched MeSH terms: Bone Density Conservation Agents/adverse effects
INTRODUCTION: Glucocorticoid therapy is associated with an appreciable risk of bone loss leading to fractures that require expensive treatments. This study aimed to evaluate the cost-effectiveness of bisphosphonates for prevention of hip fracture in glucocorticoid-induced osteoporosis (GIOP) in Malaysia.
METHOD: Retrospective data were collected from GIOP patients referred to the Universiti Kebangsaan Malaysia Medical Centre. Fracture events and direct medical costs were compared between bisphosphonates and calcium/vitamin D combination.
RESULTS: Fracture events were reported in 28 out of 93 included patients, with hip and vertebral fractures representing 42.9% and 35.7%, respectively. Overall, the use of bisphosphonates could not be considered cost-effective for treatment of all GIOP patients. The presence of certain fracture risk factors was able to modify the cost-effectiveness of bisphosphonates. Bisphosphonates was considered cost-effective if started in patients more than 60 years old. However, the use of bisphosphonates was not cost-effective in GIOP patients with secondary osteoporosis. The incremental cost-effectiveness ratios (ICER) of bisphosphonates in patients with risk factors of previous fracture or rheumatoid arthritis were Malaysian Ringgits (MYR) 108 603.40 and MYR 25 699.21, respectively.
CONCLUSION: Fracture risk factors of age, previous fracture, rheumatoid arthritis and secondary osteoporosis may modify the cost-effectiveness outcomes of bisphosphonates. Bisphosphonates would be considered cost-effective in patients more than 60 years old as compared to calcium/vitamin D treatments. Further evaluation of the impact of fracture risk factors in larger populations would provide more precise information to better assist rational and economical use of anti-osteoporosis treatment in GIOP patients.
Matched MeSH terms: Bone Density Conservation Agents/adverse effects