CompletedPhase 4ACTRN12615001027505

Effect of Nitrates on Bone Density

Efficacy of nitrates on bone mineral density in postmenopausal women with osteopenia

Sponsor

University of Auckland

Enrollment

240 participants

Start Date

Sep 20, 2016

Study Type

Interventional

Conditions

Osteoporosis

Summary

Fractures occur in more than 50% of older women. Low bone density is a strong risk factor for fracture, but 80% of fractures occur in women with only mildly low bone density. Currently, there are no acceptable evidenced-based treatments for these women. Small studies have suggested that organic nitrates, which are commonly used to treat heart disease, might increase bone density. We plan to systematically investigate their effects on bone density. We will undertake a 2-year randomised, placebo-controlled trial of 5 different doses of organic nitrates in post-menopausal women with mildly low bone density. Participants will receive organic nitrates or inactive treatment for 1 year and then will be followed without treatment for 1 year. The main outcome is the change in bone density. If the treatment is effective, the study will provide the evidence base for a large trial to be conducted to test whether these agents can prevent fractures.

Eligibility

Sex: FemalesMin Age: 55 Yearss

Inclusion Criteria2

Postmenopausal women aged >55 years
Bone mineral density T score at the lumbar spine, femoral neck or total hip between -1 and -2.5

Exclusion Criteria10

Bone mineral density T score <-2.5 at the total hip, femoral neck or lumbar spine
Current use of nitrate agents, or phosphodiesterase-5 inhibitors
Concurrent major systemic illness including untreated hypothyroidism or hyperthyroidism, chronic liver disease, chronic renal failure, malignancy, and active major gastrointestinal disease
Known congenital heart disease or hypotension, systolic blood pressure < 100 mmHg
Metabolic bone disease
Previous fragility fracture of the hip or clinical spine fracture
Current or past use of bisphosphonate therapy within 12 months, or any past zoledronate use
Use of oral glucocorticoid drugs equivalent to an average dose of at least prednisone 2.5mg/day during the preceding 6 months
Use of hormone replacement therapy within 12 months
Known nitrate hypersensitivity

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

Arm 1, isosorbide mononitrate 20mg daily, immediate release, oral for 1 year then no intervention for 1 year Arm 2, isosorbide mononitrate 30mg daily, sustained release, oral for 1 year then no inter

Arm 1, isosorbide mononitrate 20mg daily, immediate release, oral for 1 year then no intervention for 1 year Arm 2, isosorbide mononitrate 30mg daily, sustained release, oral for 1 year then no intervention for 1 year Arm 3, isosorbide mononitrate 60mg daily, sustained release, oral for 1 year then no intervention for 1 year Arm 4, nitroglycerin 25 mg daily, transdermal for 1 year then no intervention for 1 year Arm 5, nitroglycerin 50 mg daily, transdermal for 1 year then no intervention for 1 year Treatment adherence will be monitored in the trial by count of tablet or patches returned at the 6 month and 1 year visits.