Nitroglycerin Ointment for Preventing Bone Loss in Postmenopausal Women

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

Osteopenia and osteoporosis cause thinning of bone tissue and loss of bone density over time. The purpose of this study is to determine the safety and effectiveness of nitroglycerin ointment for the treatment of osteopenia in postmenopausal women.

Study hypothesis: On average, participants in the base therapy cohort who receive placebo ointment control and calcium/vitamin D will lose more bone density than participants in the nitroglycerin cohort over the 36-month period.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Treatments: Calcium; Ergocalciferols; Nitric Oxide; Nitroglycerin; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

• Postmenopausal for a minimum of 13 months

• Lumbar spine T-score of 0 to -2.5 (0 to -2.0 if over 60 years old) by Dual Energy X-ray Absorptiometry (DEXA) (i.e., evidence of normal bone mass or osteopenia)

• Body Mass Index (BMI) between 18 and 32

• Planning to live in the greater New Brunswick, NJ, area for at least 3 years

Exclusion Criteria:

• Radiographically or DEXA-morphometrically proven vertebral or hip fracture

• Conditions requiring routine use of sublingual, transdermal, or oral nitrates

• Significant postmenopausal symptoms that require estrogen therapy

• Metabolic bone diseases other than postmenopausal bone loss (e.g., active hyperthyroidism, hyperparathyroidism, Paget's disease of bone, etc.)

• Insulin-dependent diabetes mellitus

• Significant migraine headaches

• History of renal calculi

• Cancer within 5 years prior to study entry

• Any condition causing an anticipated life expectancy of less than 3 years

• Failure to maintain 75% to 125% compliance with open-label calcium with vitamin D regimen during the screening period