Nitroglycerin Ointment for Preventing Bone Loss in Postmenopausal Women

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-07-31

Study Completion Date

2007-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Nitrate and Bone Study: Effects of Nitrates on Osteoporosis

NCT00252421

Osteoporosis

COMPLETED PHASE3

Nitrates and Bone Turnover; Nitrates and Bone Turnover Bisphosphonate Sub-Study

NCT01387672

Osteoporosis

COMPLETED PHASE3

Study to Evaluate AMG 162 in the Prevention of Postmenopausal Osteoporosis

NCT00091793

Postmenopausal Osteoporosis

COMPLETED PHASE3

Phase 2 Safety and Efficacy Study of a Vitamin D Compound (DP001) in Postmenopausal Women With Low Bone Mineral Density

NCT00715676

Osteoporosis

COMPLETED PHASE2

Osteoporosis Prevention With Low Dose Alendronate

NCT00463268

Osteopenia

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoporosis Osteopenia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nitroglycerin ointment

Intervention Type DRUG

Calcium supplement with vitamin D

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes