The Nitrate and Bone Study: Effects of Nitrates on Osteoporosis

NCT00252421 | Completed Phase 3 DMC

• 2 other identifiers: 05-169ISRCTN 94484747
• Study Type: interventional
• Target: 243
• Locations: 1 country
• Sites: 1

Brief Summary

Osteoporosis or "thinning of the bones" affects in 1 in 4 Canadian women and 1 in 8 Canadian men. Moreover, while the rates of osteoporosis among Canadians are stabilizing, worldwide the number of people afflicted with osteoporosis continues to rise. The most serious complication of osteoporosis is a broken bone or fracture. Fractures due to osteoporosis can result in long hospital stays, dependence on others, and premature death. While there are several medications that prevent osteoporosis they all have side effects. For example, postmenopausal women who take hormone replacement therapy (HRT) are at increased risk of breast cancer and heart disease. In addition, drugs to prevent osteoporosis are expensive and not available worldwide. Therefore, it is essential that researchers continue to identify and test new medications for the prevention of osteoporosis. The purpose of the research is to determine if nitrates, a group of drugs that are widely available, inexpensive, and commonly used to treat chest pain or angina, can prevent osteoporosis in women. If the researchers find that nitrates prevent osteoporosis, a widely available, inexpensive treatment for osteoporosis prevention that does not have any long term side effects would have been identified. This will improve the health of patients with osteoporosis worldwide.

Conditions

Osteoporosis

Keywords

osteoporosis; bone mineral density; nitrates

Outcome Measures

Primary Outcomes (2)

• Pilot Study: Mean headache score associated with each of intermittent nitroglycerin ointment (NTG) and isosorbide mononitrate (ISMO) use

  6 months

• Main Study: Change from baseline in bone mineral density (BMD) at the lumbar spine over 24 months

  48 months

Secondary Outcomes (1)

• Change from baseline in total hip BMD; Change from baseline in bone formation and bone resorption markers; Adverse events and Bone microarchitecture: trabecular and cortical volumetric bone densities at the radius and tibia.

  48 months

Study Arms (2)

Nitroglycerin

ACTIVE COMPARATOR

Nitroglycerin ointment 15 mg/day daily for 24 month

Drug: Nitroglycerin ointment 15 mg/day daily for 24 month

Placebo

PLACEBO COMPARATOR

Placebo ointment daily for 24 month

Drug: Placebo ointment daily for 24 month

Interventions

Nitroglycerin ointment 15 mg/day daily for 24 month DRUG

Nitroglycerin ointment 15 mg/day applied daily for 24 mth

Nitroglycerin

Placebo ointment daily for 24 month DRUG

Placebo ointment applied daily for 24 mth

Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 50 and older
• Lumbar spine BMD (L1 to L4) T score between 0 and -2.0
• At least 3 years postmenopausal

You may not qualify if:

• Prior low trauma hip or vertebral fracture
• Total hip or femoral neck T score of \<-2.0
• Bone disorders other than osteopenia (e.g., hyperparathyroidism or Paget's disease)
• Treatment within six months of study entry with androgen, calcitonin, estrogen, progesterone, fluoride in a tablet form, raloxifene, tamoxifen, etidronate, prednisone or an equivalent at 5 mg/d for 12 months or greater, lithium or anticonvulsants
• Alendronate or risedronate use for at least four weeks, within the last three years
• Current treatment with nitrates
• Systolic blood pressure of =\<100 mm Hg or diastolic blood pressure \>=100 mm Hg at the baseline screening examination
• Abnormal electrocardiogram (ECG) at the baseline screening examination
• history of myocardial infarction, angina, valvular or congenital heart disease
• Disabling conditions that may interfere with follow-up visits
• Inability to give informed consent
• Migraine headaches
• Hypersensitivity to nitrates

Sponsors & Collaborators

• University of Toronto: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

Location

Related Publications (1)

• Jamal SA, Cummings SR, Hawker GA. Isosorbide mononitrate increases bone formation and decreases bone resorption in postmenopausal women: a randomized trial. J Bone Miner Res. 2004 Sep;19(9):1512-7. doi: 10.1359/JBMR.040716. Epub 2004 Jul 26.

  PMID: 15312252 BACKGROUND

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Sophie A. Jamal, MD, PhD

  Women's College Hospital, St. Michael's Hospital, University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor/Endocrinologist

Study Record Dates

• First Submitted: November 10, 2005
• First Posted: November 11, 2005
• Study Start: October 1, 2005
• Primary Completion: June 1, 2010
• Study Completion: July 1, 2010
• Last Updated: May 21, 2014

Record last verified: 2014-05

Locations

CA (1)