Effect of Nitrates on Bone Density

Phase 4

Completed

• Conditions: Osteoporosis; Musculoskeletal - Osteoporosis

• Registration Number: ACTRN12615001027505
• Lead Sponsor: niversity of Auckland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-01
• Study Completion: 2018-10-31
• Last Update Posted: 21 February 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 240

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in lumbar spine bone mineral density assessed on DXA scans[1 year]

Secondary Outcome Measures

Name	Time	Method
Change in total hip bone mineral density assessed on DXA scans[1 year];Change in femoral neck bone mineral density assessed on DXA scans[1 year];Change in total body bone mineral density assessed on DXA scans[1 year];Change in markers of bone turnover (procollagen type-I N-terminal propeptide, P1NP, and Beta-C-terminal telopeptide of type I collagen, CTX, assessed using via serum assay)[1 year];Change in markers of bone turnover (procollagen type-I N-terminal propeptide, P1NP, and Beta-C-terminal telopeptide of type I collagen, CTX, assessed using via serum assay)[2 years];Change in lumbar spine bone mineral density assessed on DXA scans[2 years];Change in total hip bone mineral density assessed on DXA scans[2 years];Change in femoral neck bone mineral density assessed on DXA scans[2 years];Change in total body bone mineral density assessed on DXA scans[2 years]