|
Treatment of Childhood Osteoporosis with Alendronate (Fosamax) Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Treatment of Childhood Osteoporosis with Alendronate (Fosamax) conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Treatment of Childhood Osteoporosis with Alendronate (Fosamax) Clinical research trials and Treatment of Childhood Osteoporosis with Alendronate (Fosamax) healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Treatment of Childhood Osteoporosis with Alendronate (Fosamax). Treatment of Childhood Osteoporosis with Alendronate (Fosamax) Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Treatment of Childhood Osteoporosis with Alendronate (Fosamax) clinical trial. Subjects frequently obtain the most expert healthcare possible for their Treatment of Childhood Osteoporosis with Alendronate (Fosamax) condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "T" Clinical Trials Conditions > Treatment of Childhood Osteoporosis with Alendronate (Fosamax)  Treatment of Childhood Osteoporosis with Alendronate (Fosamax)
Treatment of Childhood Osteoporosis with Alendronate (Fosamax)
For Condition: Osteoporosis
Status: Completed
Sponsor(s): National Institute of Child Health and Human Development (NICHD) ,
Synopsis: Bones grow and stay strong through a continuous process of formation (building) and resorption (break down). When more bone is formed than resorbed, the density (level of calcium) in bone increases and the bones become stronger. However, if more bone is resorbed than formed the density of bone decreases and the bones become weak. This condition is called osteoporosis. Osteoporosis is a rare but serious condition in children. Childhood osteoporosis can occur without a known cause (idiopathic juvenile osteoporosis). Children with osteoporosis suffer from pain, inability to stay active, and increased amounts of broken bones, including fractures of the spine. Even mild childhood osteoporosis may have long-term consequences since individuals who achieve a less than normal bone composition (peak bone mass) during the first 20-30 years of life may be at an increased risk for osteoporosis as adults. Alendronate (Fosamax) is a drug that works by stopping bone resorption (break down). It has been used to treat post-menopausal osteoporosis, male osteoporosis and adults with osteoporosis due to long-term steroid therapy. The goal of this study is to determine the effectiveness of alendronate in children with idiopathic juvenile osteoporosis. Researchers believe that children treated with alendronate will improve bone strength and decrease the amount of fractures caused by osteoporosis.
Details: Osteoporosis is a rare but serious condition in children. One of the least well understood forms of childhood osteoporosis is idiopathic juvenile osteoporosis. Affected children suffer from pain, decreased activity tolerance, and increased fractures, including vertebral compression fractures. Even mild childhood osteoporosis may have long-term consequences since individuals who achieve a lower peak bone mass during the first 2-3 decades of life may be at increased risk for osteoporosis as adults. Alendronate (Fosamax™ (Trademark), Merck & Co.), an aminobisphosphonate, is a potent inhibitor of bone resorption. It has been used to treat postmenopausal osteoporosis, idiopathic male osteoporosis, and glucocorticoid induced osteoporosis in adults. The goal of this protocol is to evaluate the effectiveness of Alendronate in children with glucocorticoid induced and idiopathic juvenile osteoporosis using a double-blind, randomized, placebo-controlled study design. We hypothesize that children treated with this drug will have an improvement in bone mineral density and decrease in osteoporotic fractures.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Chronological age: 6.0 - 17.0 years. Study population will be restricted to children greater than 12 years of age until 8 patients have completed 6 months of the study or safety data is available from a comparable study. AP Lumbar spine bone mineral density less than or equal to -2 standard deviations for age matched controls (z-score) using Hologic QDR machine. Normative data published by Faulkner will be used to calculate Z-scores. Patients with Idiopathic Juvenile Osteoporosis, osteoporosis (BMD less than -2 SD compared to age-matched controls) in a child with no identifiable etiology. Children with IJO and delayed puberty will have their z-score calculated on the basis of bone age. EXCLUSION CRITERIA: Inability to swallow pills or comply with administration instructions. Upper gastrointestinal tract disease. Creatinine clearance greater than or equal to 35 mL per min per 1.73 square meters. Prior treatment with bisphosphonates. Concurrent therapy with oral aspirin or salicylate containing compounds, excluding delayed-release salicylates which act in the distal gastrointestinal tract (for example, mesalamine, sulfasalazine, etc...). Hypocalcemia. Treatment with hGH or calcitonin in the preceding 6 months. Inability to undergo dual energy x-ray absorptiometry. Positive pregnancy test. In females, sexual activity without an effective method of contraception.
Total Enrollment: 50
Location and Contact Information:
National Institute of Child Health and Human Development (NICHD)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 980077; 98-CH-0077
Study Start Date: March 17, 1998
Record last reviewed: June 4, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001720
Other Osteoporosis Studies:
1. Hormone Replacement in Young Women with Premature Ovarian Failure
2. Risedronate in Preventing Bone Loss in Premenopausal Women Receiving Chemotherapy for Primary Breast Cancer
3. Treatment of Calcium Deficiency in Young Women
4. Osteoporosis Prevention: Changes to Exercise and Diet in Children
5. Can parathyroid hormone injections reverse glucocorticoid-induced osteoporosis
Related Studies:
Other Osteoporosis Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Treatment of Childhood Osteoporosis with Alendronate (Fosamax)
|
|
|
|
|
|
|
|
