Track topics on Twitter Track topics that are important to you
We have previously evaluated the safety and efficacy of Fosamax in 10 patients with juvenile osteoporosis during a 12-month clinical trial. We have documented that Fosamax improved BMD of the spine and hip without any major side effects. There were no additional fractures during therapy. The present study is designed to further evaluate the safety and efficacy of Fosamax in 20 children with juvenile osteoporosis using a double-blind, randomized, placebo-controlled, cross-over protocol.
Osteoporosis is an uncommon disease in children and early adolescents. Patients have a low bone mineral density, develop fractures with minimal or no trauma, and frequently have a negative family history. The disease results from either diminished bone formation or increased bone removal (resorption). No specific drug therapy has been recommended for juvenile osteoporosis. Alendronate (Fosamax) is effective in inhibiting bone resorption, increasing BMD and reducing fractures in adults with postmenopausal osteoporosis, but have not become established therapies in children. In the present study, we plan to evaluate the safety and efficacy of Fosamax in 20 patients with juvenile osteoporosis in a two-year period. This is a randomized, double-blind, placebo-controlled protocol. In the year-1, 10 patients will be assigned to receive Fosamax and 10 patients placebo. In the year-2, patients will be crossed over to the second arm of the study. Those who received Fosamax in the year-1, will receive placebo in the second year and vice versa. The patients will have 5 visits, the initial screening visit followed by 4 post therapy visits in a six-month interval. Measurements include DEXA of spine and hip, urinalysis and blood work.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Medical University of South Carolina
Medical University of South Carolina
Published on BioPortfolio: 2014-08-27T03:47:24-0400
This 2-year study will test the effectiveness of combining parathyroid hormone (PTH) and alendronate for treating osteoporosis in postmenopausal women. Alendronate is a drug used to treat ...
Osteopenia and osteoporosis are being described more frequently in people with HIV infection. This study will test the efficacy of alendronate in comparison with a placebo after 2 years, i...
Osteoporosis, a condition in which bones are fragile and break easily, is a major health problem for postmenopausal women. Research studies have shown that both estrogen/progestin replacem...
OBJECTIVES: I. Determine the bioavailability and biologic effect of alendronate on bone metabolism in patients with cystic fibrosis. II. Assess the safety and efficacy of this treatment...
Osteoporosis is a disease that affects millions of individuals in the United States and abroad. It leads to decreased bone mass and causes an increased risk of fracture. This study will co...
Mineral and bone disorders including osteoporosis are common in dialysis patients and contribute to increased morbimortality. However, whether denosumab and alendronate are effective and safe treatmen...
Retraction: Paper "Comparison of Effect of Treatment with Etidronate and Alendronate on Lumbar Bone Mineral Density in Elderly Women with Osteoporosis" by Iwamoto J, et al. Yonsei Med J 2005;46(6):750-758.
This corrects the article on p. 750 in vol. 46, PMID: 16385649.
Given the widespread practice of recommending drug holidays, we reviewed the impact of medication discontinuation of two common anti-osteoporosis therapies (bisphosphonates and denosumab). Trial evide...
A gold therapeutic nanoplatform with the same molecule used as reductant, coating and therapeutic agent has been developed in a one-pot, one-phase process using alendronate, a drug from the bisphospho...
A nonhormonal medication for the treatment of postmenopausal osteoporosis in women. This drug builds healthy bone, restoring some of the bone loss as a result of osteoporosis.
Reduction of bone mass without alteration in the composition of bone, leading to fractures. Primary osteoporosis can be of two major types: postmenopausal osteoporosis (OSTEOPOROSIS, POSTMENOPAUSAL) and age-related or senile osteoporosis.
The mineral component of bones and teeth; it has been used therapeutically as a prosthetic aid and in the prevention and treatment of osteoporosis.
Breaks in bones resulting from low bone mass and microarchitectural deterioration characteristic of OSTEOPOROSIS.
An aminobisphosphonate derivative of etidronic acid and CALCIUM CHANNEL BLOCKER that inhibits BONE RESORPTION and is used for the treatment of OSTEOPOROSIS.
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
Pediatrics is the general medicine of childhood. Because of the developmental processes (psychological and physical) of childhood, the involvement of parents, and the social management of conditions at home and at school, pediatrics is a specialty. With ...