Nitroglycerin Ointment for Preventing Bone Loss in Postmenopausal Women

National Institutes of Health (NIH)

Status and phase

Completed

Phase 3

Conditions

Osteopenia

Osteoporosis

Treatments

Drug: Calcium supplement with vitamin D

Drug: Nitroglycerin ointment

Study type

Interventional

Funder types

NIH

Identifiers

NCT00043719

NOVEL

R01AR048679

NIAMS-069

Details and patient eligibility

About

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.

Full description

Imbalance in the activities of osteoclasts (cells responsible for bone loss) and osteoblasts (cells responsible for bone formation) may lead to fractures, osteopenia, and osteoporosis in postmenopausal women. During postmenopause, decreased estrogen levels and decreased nitric oxide production occur; estrogen replacement therapy has been shown to restore serum nitric oxide levels to normal. Reversing nitric oxide deficiency by using nitroglycerin may prevent further bone loss. The Nitroglycerin as an Option: Value in Early Bone Loss (NOVEL) study will test the safety and efficacy of nitroglycerin ointment for the treatment of osteopenia in postmenopausal women.

Patients will be enrolled in the study for 3 years and will be randomly assigned to one of two groups. The first group will receive nitroglycerin ointment, while the second group will receive placebo ointment. All patients will be given a calcium supplement with vitamin D to be taken daily, and will be instructed to rub the given ointment on their skin daily. Study visits will occur at Month 2 and every six months after Month 2. Phone interviews will be conducted with patients every 2 months throughout the study.

Sex

Female

Ages

40 to 65 years old

Volunteers

Accepts Healthy Volunteers

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