Unregistered User If this is not your name, click here.
		Contact Us | Order Now | Journals | Bookstore | Register a colleague
	Select a ChannelAcneAIDS and HIVAllergy OtherAlzheimer'sAnaesthesiology OtherAngina Pectoris/MIAnxietyArthritis OtherAsthmaBack PainBacterial InfectionsBladder CancerBone Marrow TransplantationBreast CancerCardiology OtherCataractCell TransplantationCervical CancerCholesterol/Lipid disordersCirrhosisClinical PharmacologyColorectal CancerCongestive Heart FailureContact DermatitisContraceptionCOPDCystic FibrosisDental and Oral DisordersDepressionDermatology OtherDiabetesDialysisEating DisordersElbowEmergency MedicineEndocrinology OtherEpilepsyErectile DysfunctionFibromyalgiaGastro OtherGeneticsGenitourinary OtherGeriatricsGERD/GastritisGlaucomaH. Pylori/UlcerHaematology OtherHair LossHeadachesHepa/Biliary OtherHepatitisHipHRTHypertensionIBDImmunologyInfectious OtherInfertilityIntensive CareIrritable Bowel SyndromeKneeLeukemiasLiver CancerLung CancerLupusLymphomasMelanomaMenopauseMultiple Sclerosis Nephrology OtherNeurologic OtherNutritional / Metabolic OtherOb/Gyn OtherObesityOncology OtherOphth. OtherOphthalmic SurgeryOrgan TransplantationOrthopaedics OtherOsteoarthritisOsteoporosisOtitisOtorhino. OtherOvarian CancerPaediatricsPainPancreatic CancerParkinson'sPregnancyProstate CancerPsychiatry OtherPulmonary OtherRadiologyRenal CancerRenal FailureRespiratory InfectionsRheumatoid arthritisRheumatology OtherRhinitisSchizophreniaShoulderSleep ApnoeaSleep DisordersSpineStrokeSTDsSurgeryThyroid DisordersTransfusionTransplant Surgery OtherTraumaUrinary IncontinenceUrinary tract infectionsVaccinologyVascular DisordersViral Infections

SEARCH   News Bookstore Medline The Web Meetings & Congresses Complete Doctor's Guide    EXPLORE :    All News   All Webcasts   All Cases   All Meetings & Congresses   All Medical Resources New drugs / indications English Dictionary Medical Dictionary Thesaurus Warning | Privacy | Awards  Favourite Journals  Click here to choose your favourite journals  Favourite Sites  Click here to choose your favourite sites  Languages  Select languageEnglishFrançais

ENDO 99: Fosamax Produces Greater Increases In Bone Density At Spine And Hip SAN DIEGO, CA -- June 15, 1999 -- The results of a one-year study show Fosamax® (alendronate sodium; Merck) tablets produced significantly greater increases in bone mineral density (BMD) at both the spine and hip than Miacalcin® (calcitonin-salmon; Novartis) nasal spray in patients postmenopausal osteoporosis. This was the first clinical study to compare the recommended treatment dosages for these two drugs. The effect of calcitonin nasal spray on BMD was not significantly different at the spine or hip trochanter from the effect of a placebo tablet. At the femoral neck of the hip, calcitonin maintained BMD at the baseline level. BMD currently is the most accurate predictor of fracture risk from osteoporosis. "Fosamax tablets and calcitonin nasal spray are two of the most commonly prescribed treatments for osteoporosis in postmenopausal women, but there have not been any head-to-head studies comparing recommended dosages of the two products," said Robert Downs, M.D., professor of medicine, Virginia Commonwealth University’s Medical College of Virginia. Dr. Downs presented the findings from his study at the 81st Annual Meeting of the Endocrine Society, ENDO 99. "This one-year study was designed to compare the efficacy of the two products and to assess tolerability." These comparative results need to be confirmed in other studies,” he added. Fosamax is indicated in postmenopausal women for the prevention and treatment of osteoporosis, and for the prevention of fracture in postmenopausal women with osteoporosis. Calcitonin nasal spray is indicated for the treatment of postmenopausal osteoporosis in women more than five years post-menopause who refuse or cannot tolerate estrogens or in whom estrogens are contraindicated. The first year of the study included 299 postmenopausal women with osteoporosis and was conducted at 24 centers in the US. The study was designed as a one-year study (12 months) with a one-year extension (24 months total). During the second year, the alendronate placebo arm will be discontinued and all patients will receive either open-label Fosamax tablets or calcitonin nasal spray. The study was funded by Merck & Co., Inc. Women in the study were randomized to receive either Fosamax (10 mg once-daily, N=118), alendronate placebo (N=58), or open-label calcitonin nasal spray (200 IU once-daily, N=123) for one year. Administration of Fosamax or placebo was double-blinded; the pills were administered according to dosing instructions for Fosamax. The marketed form of calcitonin nasal spray was administered open-label. Intranasal placebo was unavailable for the study. Per standard medical practice, patients were supplemented with vitamin D and calcium. All patients were given 400 IU vitamin D daily and a calcium supplement, if necessary, to ensure a daily intake of at least 1,000 mg elemental calcium. BMD was measured by dual x-ray absorptiometry at baseline, six months and 12 months. The primary endpoint of the study design was BMD of the lumbar spine at 12 months. Treatment groups were of sufficient size to detect a 2 percent difference in efficacy between Fosamax and calcitonin nasal spray (statistical power greater than 90 percent). Secondary endpoints for the study include: hip trochanter and femoral neck BMD at 12 months; lumbar spine, hip trochanter and femoral neck BMD for up to 24 months; and biochemical markers of bone turnover for up to 24 months. Safety and tolerability were assessed throughout the study by periodic physical exams, laboratory evaluations and reporting of adverse events. Patient compliance was assessed using patient reporting and study coordinator evaluation of medication usage. There were no differences of statistical significance in the compliance rates between the three treatment groups. The patients enrolled in the study were 45 to 84 years of age (average age 64 years) and were at least five years post-menopause (16 years post-menopause on average). There were no significant differences between treatment groups in terms of other risk factors for osteoporosis including race, age, caffeine intake, smoking history, family history of osteoporosis or dietary calcium intake. At the end of one year, Fosamax produced significantly greater increases in BMD than calcitonin nasal spray at both the lumbar spine (primary endpoint) and hip (secondary endpoints). A significant difference in BMD in the group treated with Fosamax, as compared to the group treated with calcitonin nasal spray, was observed at the lumbar spine and hip trochanter as early as the first measurement at six months, and persisted at the 12-month measurement. At 12 months, a significant increase in BMD also was seen at the femoral neck of the hip with Fosamax as compared to calcitonin nasal spray. In the calcitonin nasal spray group, BMD changes at the lumbar spine and hip trochanter were not statistically different from placebo at any point in the study. At the femoral neck of the hip, the calcitonin group demonstrated a statistically significant difference in BMD relative to placebo, while the placebo group experienced a loss of BMD at the femoral neck. Changes in BMD at 12 months relative to baseline were as follows: -- At the lumbar spine (primary endpoint), there was a statistically significant 5.2 percent increase in BMD from baseline in the treatment group receiving Fosamax, a statistically significant 1.2 percent increase in the calcitonin group, and a non-significant 0.2 percent increase in the group receiving placebo. -- At the hip trochanter, BMD was significantly increased by 4.7 percent from baseline in the group treated with Fosamax, the group treated with calcitonin had a non-significant 0.5 percent increase, and there was a 0 percent change with placebo. -- At the femoral neck of the hip, there was a significant 2.8 percent increase in BMD from baseline in the treatment group receiving Fosamax, a non-significant 0.6 percent increase with calcitonin, and a significant 1.3 percent decrease with placebo. Fosamax Well-Tolerated Fosamax was generally well-tolerated in the study. These findings are consistent with prior clinical studies with Fosamax. Adverse experiences related to the gastrointestinal (GI) tract were reported more commonly in both the blinded groups treated with Fosamax and alendronate placebo than in the group given open-label calcitonin nasal spray. Respiratory and nasal adverse experiences were reported more commonly in the calcitonin nasal spray group. "The safety profiles of these products are well documented in clinical trials; both are tolerated well when dosed properly," said Dr. Downs. "In this comparative study we saw that Fosamax was not only well-tolerated, but it also had significantly greater efficacy than calcitonin nasal spray." Related Links: Fosamax, Merck, Miacalcin, Novartis E-mail this page to a friend or colleague! To print, use this version