Bisphosphonate Action on the Appendicular Skeleton: Evidence for Differential Effects

NCT00666627 | Completed Phase 2 DMC

• 1 other identifier: STH 14463
• Study Type: interventional
• Target: 410
• Locations: 1 country
• Sites: 1

Brief Summary

A study to determine if the three licensed bisphosphonates (alendronate, ibandronate and risedronate):a) affect the peripheral skeleton differently, as assessed by quantitative ultrasound of bone (QUS), peripheral quantitative computed tomography (pQCT) and dual-energy x-ray absorptiometry (DXA)? b) have different effects on bone cells and their activity as assessed by flow cytometry and biochemical markers of bone cell activity? The aim of the study is to compare the effects of three licensed bisphosphonates on bone quantity and quality. There has been no such study before. Most of the measures of bone quantity and quality used in this protocol have not been studied with any of these three agents. The novelty of the study necessitates the establishment of reference ranges and this explains the need for the inclusion of a group of young women.

Conditions

Post-menopausal Osteoporosis

Keywords

Osteoporosis; Post-menopausal osteoporosis; Bisphosphonates; Alendronate; Ibandronate; Risedronate

Outcome Measures

Primary Outcomes (1)

• Change in heel broadband ultrasound attenuation

  2 years

Secondary Outcomes (9)

• Changes in the percentage of MCSFR+ monocytes in the peripheral blood at baseline and after one week and 48 weeks of therapy

  2 years

• Change in SOS at finger and heel at 48 weeks.

  2 years

• Change in lumbar spine and total hip BMD measured by DXA at 48 weeks

  2 years

• Change in finger BMD measured by RA at 48 weeks

  2 years

• Change in heel BMD measured by DXL at 48 weeks

  2 years

Study Arms (4)

1

ACTIVE COMPARATOR

Ibandronate

Drug: Ibandronate

2

ACTIVE COMPARATOR

Risedronate

Drug: Risedronate

3

ACTIVE COMPARATOR

Alendronate 70mg once weekly

Drug: Alendronate

4

NO INTERVENTION

Young women control group

Interventions

Ibandronate DRUG

once monthly

Also known as: Bonviva

1

Risedronate DRUG

Risedronate 35mg once weekly

Also known as: Actonel

2

Alendronate DRUG

Alendronate 70mg once weekly

Also known as: Fosamax

3

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• be female
• at least 5 years post menopausal but \<85 years
• BMD T-score (at the lumbar spine or total hip) of less than or equal to
• , or T-score less than or equal to -1 with a low trauma fracture.
• be ambulatory
• be able and willing to participate in the study and provide written informed consent

You may not qualify if:

• have evidence of a clinically significant organic disease which could prevent the patient from completing the study
• have a BMI less than 18 or greater than 35
• abuse alcohol or use illicit drugs or who consumed more than 4 servings of any alcoholic beverage one day prior to the visit (i.e., subjects who might be binge drinkers)
• have any history of cancer within the past 5 years excluding skin cancer non melanomas
• have 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 TSH outside the lower limit of the normal range
• Hyperparathyroidism
• Hypocalcemia or hypercalcemia
• Osteomalacia
• Cushing's syndrome
• Patient who are currently on glucocorticoid therapy
• have a serum calcium less than 2.2 mmol/l and a PTH above 75ng/l

Sponsors & Collaborators

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

Study Sites (1)

Academic Unit of Bone Metabolism (Sheffield)

Sheffield, South Yorkshire, S5 7AU, United Kingdom

Location

MeSH Terms

Conditions

Osteoporosis, Postmenopausal; Osteoporosis

Interventions

Ibandronic Acid; Risedronic Acid; Alendronate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Eugene McCloskey, Dr

  University of Sheffield

  STUDY DIRECTOR

• Rosemary Hannon, Dr

  University of Sheffield

  STUDY DIRECTOR

• Angela Rogers, Dr

  University of Sheffield

  STUDY DIRECTOR

• Margaret Paggiosi, Dr

  University of Sheffield

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 23, 2008
• First Posted: April 25, 2008
• Study Start: April 1, 2007
• Primary Completion: September 1, 2012
• Study Completion: December 1, 2014
• Last Updated: March 6, 2018

Record last verified: 2018-03

Locations

GB (1)