Resolution of Effect of Bisphosphonates on Bone in Postmenopausal Osteoporosis

NCT01406613 | Completed

• 1 other identifier: STH15387
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

This is a 2year observational study that will recruit patients who have previously completed a randomised, open label, parallel, single centre study (TRIO Study) of three bisphosphonates: alendronate, ibandronate and risedronate. These drugs are the most commonly used group of treatments for postmenopausal osteoporosis in the UK. However, the length of time for which these treatments continue to work after they are stopped has not been fully elucidated. Without this information it is unclear as to how long doctors should treat and whether it would be good practice to give drug 'holidays'. The investigators plan to compare the effects on bone quantity and quality of stopping these licensed bisphosphonates in patients who have taken the medication for a duration of two years. The investigators aim to recruit up to 100 postmenopausal and up to 100 premenopausal (reference range) subjects. Measurements collected at the final visit of the previous study will be used for 'baseline' values for this study. The postmenopausal group will have an initial study visit to secure informed consent, and then further study visits at 24, 48, 72 and 96 weeks after stopping medication. Visit procedures will include: Blood and urine samples for measurements of bone biomarkers Bone Mineral Density of the spine, hip, whole body, forearm Dual-emission X-ray absorptiometry (DXA), and heel dual X-ray and Laser (DXL) Quantitative Ultrasound of Bone (QUS) Vertebral Fracture Assessment (VFA). The premenopausal group will have one study visit, 96 weeks after completing the previous study. Visit procedures will include: Blood and urine samples for measurements of bone biomarkers Bone Mineral Density of the spine and hip (DXA) A subgroup of 50 premenopausal women will also have the following measurements: Bone Mineral Density of the whole body, forearm (DXA), and heel (DXL) Quantitative Ultrasound of Bone (QUS).

Conditions

Postmenopausal Osteoporosis

Keywords

Observational; Bone Density; alendronate; ibandronate; risedronate; postmenopausal; osteoporosis

Study Arms (1)

Particpants of previous TRIO study

All participants to this study are being observed as a follow up to a previous study which involved 4 arms. All participants to this follow up study will be subject to identical study procedures.

Other: Observation

Interventions

Observation OTHER

In this study we will examine the changes in bone density by DXA and QUS and bone turnover after stopping Bisphosphonate treatment. As we wish to measure the speed of offset of effects of treatment we have scheduled visits at 24 week intervals in order to fully assess this effect.

Particpants of previous TRIO study

Eligibility Criteria

• Age: Up to 87 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants of previous TRIO study - women who either received treatment with alendronate, ibandronate and risedronate for postmenopausal osteoporosis in secondary care. Control premenopausal women will also be recruited.

You may qualify if:

• female be at least 7 years postmenopausal but less than 87 years of age
• be ambulatory
• be able and willing to participate in the study and provide written informed consent.
• have taken a bisphosphonate for 2 years as a participant in the TRIO study and be compliant \> 80%
• have a Bone Mineral Density (BMD) T score \> -2.5 at the femoral neck
• be able and willing to participate in the study and provide written informed consent
• have previously taken part as premenopausal controls in the TRIO study
• be in good general health as determined by past medical and physical history
• be bisphosphonate naive; premenopausal women.

You may not qualify if:

• An incident vertebral fracture or more than 5%/year bone loss at the spine or hip during the 2-year TRIO study
• Evidence of a clinically significant organic disease which could prevent the patient from completing the study, including diabetes
• Abuse of alcohol or use of illicit drugs or who consumed more than 4 units of any alcoholic beverage one day prior to the visit (i.e. subjects who might be binge drinkers)
• A history of cancer within the past 5 years excluding skin cancer non melanomas
• A history of ongoing conditions or diseases known to cause abnormalities of calcium metabolism or skeletal health (secondary osteoporosis)
• Chronic renal disease (as defined by a creatinine clearance of ≤ 30ml/min)
• Acute or chronic hepatic disease
• Malabsorption syndromes
• Hyperthyroidism as manifested by Thyrotrophin-stimulating hormone (TSH) outside the lower limit of the normal range
• Hyperparathyroidism
• Hypocalcemia or hypercalcemia
• Osteomalacia
• Cushing's syndrome
• Current use of glucocorticoid therapy
• A serum calcium less than 2.2 mmol/l and a Parathyroid hormone (PTH) above 75ng/l

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead
• University of Sheffield: collaborator

Study Sites (1)

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorks, S5 7AU, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

A venous blood sample will be collected from each participant at each visit to analyse biochemical bone markers, and basic biochemistry analysis for eligibility screening. Two urine samples will be collected from each participant at each study visit, one collected on the morning prior to the study visit and a second sample on the morning of the study visit.

MeSH Terms

Conditions

Osteoporosis, Postmenopausal; Osteoporosis

Interventions

Observation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Richard Eastell, Professor

  University of Sheffield

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2011
• First Posted: August 1, 2011
• Study Start: March 1, 2010
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: February 15, 2019

Record last verified: 2019-02

Locations

GB (1)