Nitroglycerin Ointment for Preventing Bone Loss in Postmenopausal Women

NCT00043719 | Completed Phase 3

• 3 other identifiers: R01AR048679NIAMS-069NOVEL
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoporosis; Osteopenia

Keywords

Human Female; Osteoporosis; Postmenopausal; Nitric Oxide; Nitroglycerin; Calcium; Vitamin D

Outcome Measures

Primary Outcomes (1)

• DXA-measured BMD (bone mineral density) of lumbar vertebrae (L2 to L4)

Secondary Outcomes (4)

• DXA-measured BMD of dual hips (Ward's triangle, femoral neck, and trochanter)

• serum osteocalcin

• BS-ALP

• serum N-telopeptide

Interventions

Nitroglycerin ointment DRUG

Calcium supplement with vitamin D DRUG

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): lead

Study Sites (1)

UMDNJ-Robert Wood Johnson Medical School, Department of Medicine, Division of Endocrinology

New Brunswick, New Jersey, 08903-0019, United States

Location

MeSH Terms

Conditions

Osteoporosis; Bone Diseases, Metabolic

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Sunil J. Wimalawansa, MD, PhD

  UMDNJ - Robert Wood Johnson Medical School, Division of Endocrinology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: August 12, 2002
• First Posted: August 14, 2002
• Study Start: July 1, 2002
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: February 2, 2009

Record last verified: 2009-01

Locations

US (1)