Physician and patient perceptions on the use of vitamin D and calcium in osteoporosis treatment: a European and Latin American perspective.

OBJECTIVE: Although osteoporosis treatment guidelines include recommendations for calcium and vitamin D intake, routine use of adequate supplementation often is low. This study explored the attitudes of physicians and patients towards vitamin D and calcium and patient use of both supplements. METHODS: A survey of randomly selected physicians in the United Kingdom, Mexico, and Austria, and the first seven eligible women with osteoporosis from each of their practices, was conducted. Physicians were asked to rate the importance of vitamin D and calcium in osteoporosis management on a scale of 1 to 10 (1 = not important at all, 10 = extremely important) and to estimate use of calcium and vitamin D supplements by their patients. Patients were asked about their own use of vitamin D and calcium, and their perceptions regarding these supplements. RESULTS: Altogether 151 physicians (50 in Austria, 51 in the UK, and 50 in Mexico), and 910 osteoporosis patients (350 in Austria, 212 in UK, and 348 in Mexico) completed telephone surveys. Approximately, 86%, 28%, and 46% of physicians rated importance of vitamin D and calcium as being 9 or 10 in Austria, UK, and Mexico, respectively. Overall, 50% of patients reported taking calcium and vitamin D supplements (47% of these on a daily basis and 46% on a regular basis), and 19% of patients reported that they had no discussions with their physicians about calcium, while 39% reported no discussion about vitamin D. CONCLUSIONS: Despite the recognition by physicians and patients that vitamin D and calcium are important for bone health, only a small proportion of patients regularly take supplements. This is the case even when vitamin D and calcium supplements are provided free with osteoporosis drug prescriptions, as occurs in Austria. However, these results rely on patient self-report of compliance which can lead to overestimation. In addition this study's participants may not be representative of other patient populations. This study provides additional evidence that compliance with treatment guidelines is suboptimal, and highlights the need for further study to explore the discrepancy between the highly perceived importance of vitamin D and calcium and the low use of both supplements, and to improve use among osteoporosis patients.

Disintegration/dissolution profiles of copies of Fosamax (alendronate).

OBJECTIVE: Poor quality has been reported for some generics and other copies of original products. We performed a pilot study to compare the disintegration/dissolution profiles of FOSAMAX (alendronate) 70 mg tablets with those of copies of FOSAMAX that were manufactured outside the United States. RESEARCH DESIGN AND METHODS: We used the standard United States Pharmacopeia (USP) disintegration method to evaluate FOSAMAX 70 mg tablets and 13 copies. At least 12 (n = 12) dosage units were tested for each product (except Fosmin, n = 10). The dissolution profiles of FOSAMAX and one representative copy were also compared. RESULTS: Nine copies (Osteomax, Defixal, Fosmin, Endronax, Osteomix, Genalmen, Fixopan, Osteoplus, and Fosval) disintegrated two- to ten-fold faster than FOSAMAX. Three other copies (Neobon, Regenesis, and Ostenan) disintegrated at least five-fold slower than FOSAMAX. Neobon is a softgel capsule, so special consideration was given to this different dosage form. One copy (Arendal) did not fall into either category but exhibited potentially large inter- and intra-lot variability. Dissolution of alendronate from Regenesis lagged behind that from FOSAMAX. CONCLUSION: Slower disintegration may reduce efficacy because bisphosphonates must be taken in the fasting state and contact with food or even certain beverages severely reduces bioavailability. Faster disintegration (or the use of gel-caps or other alterations to the drug formulation) could increase the risk of esophagitis, an adverse event associated with prolonged contact of the esophagus with bisphosphonates. These disintegration and dissolution results suggest that important differences may exist between FOSAMAX and its copies with regard to bioavailability, pharmacokinetics, and clinical efficacy and safety profiles. Additional testing is warranted to evaluate the pharmacokinetics and clinical safety of these copies.

Postmenopausal osteoporosis: patient choices and outcomes.

OBJECTIVE: Only two medications, estrogen and injectable salmon calcitonin, are currently approved by the FDA for the treatment of osteoporosis. Oral etidronate has been investigated but not approved for osteoporosis therapy. We compared the three available anti-resorptive medications in untreated osteoporotic women. DESIGN: A nonrandomized, open label trial. After baseline biochemistry and bone mineral density (BMD) determinations, subjects self-selected therapy based on descriptions of the three drugs which were similar for all patients. Bone densitometry of the lumbar spine, femoral neck and distal and proximal forearm sites was repeated every 6 months. RESULTS: Twenty-one patients chose estrogen, 20 chose etidronate and 11 chose calcitonin. Fear of breast cancer was the most common reason given for not choosing estrogen therapy. Mean age was slightly lower and spine and hip bone densities slightly higher in the estrogen group compared with both the etidronate and calcitonin groups. In the lumbar spine, all three agents resulted in similar small increments (mean increments 1.2-4.4% at 2 years). In the estrogen group, there was no change in femoral neck density while there were significant losses in both calcitonin and etidronate groups (3.1-4.9%). In the forearm, there was either no change (distal site) or an increment (proximal site) in the estrogen group, while both etidronate and calcitonin groups demonstrated a mean loss at both sites over the 2-year observation period. CONCLUSIONS: These preliminary results suggest that all three agents appear equally effective at maintaining or increasing BMD of the lumbar spine, while estrogen appeared more effective at maintaining or increasing BMD of the appendicular skeleton. This study underscores the need for an alternative to estrogen therapy which is equally effective and can be given orally for those in whom estrogen is either contraindicated or undesirable.