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PaTH Study: Parathyroid Hormone and Alendronate for Osteoporosis Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about PaTH Study: Parathyroid Hormone and Alendronate for Osteoporosis conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. PaTH Study: Parathyroid Hormone and Alendronate for Osteoporosis Clinical research trials and PaTH Study: Parathyroid Hormone and Alendronate for Osteoporosis health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like PaTH Study: Parathyroid Hormone and Alendronate for Osteoporosis. PaTH Study: Parathyroid Hormone and Alendronate for Osteoporosis Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a PaTH Study: Parathyroid Hormone and Alendronate for Osteoporosis clinical trial. Human subjects often get the best healthcare available for their PaTH Study: Parathyroid Hormone and Alendronate for Osteoporosis condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > PaTH Study: Parathyroid Hormone and Alendronate for Osteoporosis  PaTH Study: Parathyroid Hormone and Alendronate for Osteoporosis
PaTH Study: Parathyroid Hormone and Alendronate for Osteoporosis
For Condition: Osteoporosis
Status: No longer recruiting
Sponsor(s): National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) ,
Synopsis: 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 osteoporosis and primarily prevents bone loss, whereas PTH increases bone formation. We will treat the study participants either with PTH and alendronate, alendronate alone, or PTH alone. We will determine the effects of these treatments by looking for changes in bone mineral density in the hip and spine.
Details: The PaTH study is a 2-year, multicenter, double-blind, placebo-controlled trial to test the efficacy of combining hPTH (1-84) and alendronate for treating osteoporosis in postmenopausal women. 238 women were randomized between 55 and 85 years of age to receive either: (1) PTH for 1 year followed by alendronate for 1 year; (2) PTH and alendronate for 1 year followed by alendronate for 1 year; (3) alendronate for 2 years; or (4) PTH for 1 year followed by placebo for 1 year. The primary endpoints are changes in bone mineral density at several sites and changes in biochemical markers. In addition, we will assess specific biochemical markers of bone turnover (e.g., osteocalcin, deoxypridinoline, N-telopeptide, bone-specific alkaline phosphatase and bone sialoprotein) to determine if they can predict the skeletal response to combination therapy. We will also determine whether PTH positively affects ultrasound measurements in the calcaneus.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 55 Years/85 Years
Genders: Female
Protocol Entry Criteria: Inclusion Criteria: - Aged between 55 and 85 years - Postmenopausal (have not had any menses in the last 5 years) - Have a bone mineral density scan (DXA) that can be evaluated at the spine AND at the hip with a T-score equal to or below -2.5 at the spine or the femoral neck or total hip OR T-score equal to or below -2.0 at the spine or the femoral neck or total hip and have at least one of the following risk factors for fracture: (a) age > 65 years; (b) history of postmenopausal fracture (nonvertebral or vertebral); or (c) maternal history of hip fracture - Willing and able to self-administer daily injections Exclusion Criteria: - Have used estrogen (oral or patch) for more than 1 month in the last 6 months or more than 12 months in the last 2 years - History of more than 12 months of bisphosphonate use ever, or any use (> 4 weeks) within the past 12 months - History of rhPTH (recombinant human PTH) use - Any major life-threatening illnesses - Type 1 or uncontrolled type 2 diabetes mellitus (defined as hemoglobin A1C > 10.0), or currently using insulin - Vitamin D level < 15 nanograms/ml - History of kidney disease (creatinine > 2.0 mg/dl) - Renal insufficiency (creatinine clearance < 40 mg/min) - Any history of kidney stones - Any history of hypercalciuria or currently have urine calcium/creatinine >300 mg - History of hypercalcemia, sarcoidosis, or hyperparathyroidism - History of active or treated tuberculosis or other granulomatous disorders - History of breast cancer, melanoma, or hematologic malignancy that has required treatment within the last 10 years - History of bone cancer or any other metabolic bone disease that has required treatment within the last 10 years - History of any other nonskin cancer that has required treatment within the last 10 years - History of symptomatic esophageal reflux, achalasia or esophageal stricture - Currently taking > 7.5 mg systemic prednisone or equivalent per day - Currently using > two puffs, four times/day of inhaled steroids - Currently taking anticoagulants or anticonvulsants - Have used Calcitonin within the past 3 months - Have used Raloxifene in the last 6 months or for more than 12 months in the last 2 years - Have used Tamoxifen in the last 6 months or for more than 12 months in the last 2 years - Have used fluoride for at least a month within the past 5 years - Currently taking > 1000 IU/day vitamin D or vitamin D analogues or metabolites - Currently taking thyroid hormone replacement AND have a TSH < 0.1mIU/L
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DennisBlack, Principal Investigator, University of California, San Francisco
Maine Center for Osteoporosis
Bangor, Maine, 04401
United States
Columbia University
New York City, New York, 10032
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
United States
University of Minnesota
Minneapolis, Minnesota, 55415
United States
Additional Information:
Study ID Numbers: NIAMS-045; N01-AR-9-2245
Study Start Date: October 1999
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005005
Other Osteoporosis Studies:
1. Zoledronate in Preventing Bone Loss in Premenopausal Women Receiving Chemotherapy After Surgery For Early Stage Breast Cancer
2. Risedronate in Preventing Bone Loss in Premenopausal Women Receiving Chemotherapy for Primary Breast Cancer
3. Prevention of Osteoporosis in Men with Prostate Cancer
4. Preventing Osteoporosis in Adolescent Girls
5. Women's Health Initiative (WHI)
Related Studies:
Other Osteoporosis Clinical Trials
Other Maine Clinical Trials
Other Bangor Clinical Trials
PaTH Study: Parathyroid Hormone and Alendronate for Osteoporosis
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