NCT01512446

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of bisphosphonates in long term treatment of osteoporosis.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
436

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2012

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 19, 2012

Completed
13 days until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
5.9 years until next milestone

Results Posted

Study results publicly available

January 17, 2019

Completed
Last Updated

February 12, 2019

Status Verified

January 1, 2019

Enrollment Period

1.1 years

First QC Date

January 11, 2012

Results QC Date

November 28, 2017

Last Update Submit

January 24, 2019

Conditions

Osteoporosis

Keywords

OsteoporosisOsteoporotic fracturesBisphosphonatePretreatment with bisphosphonates

Outcome Measures

Primary Outcomes (1)

  • Number of New Osteoporotic Fractures

    Number of new osteoporotic fractures. All fractures which occurred without high impact trauma (i.e. atraumatically, minor accidents and falls from standing height and lower) were regarded as osteoporotic fractures, except for fractures of fingers, face, skull and toes.

    From baseline to study termination (mean duration 5.6 months)

Secondary Outcomes (2)

  • Mortality

    From baseline to study termination (mean duration 5.6 months)

  • Combination of New Osteoporotic Fractures and Deaths

    From baseline to study termination (mean duration 5.6 months)

Study Arms (2)

Alendronate

ACTIVE COMPARATOR
Drug: Alendronate

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

AlendronateDRUG

70 mg per week

Also known as: Fosamax
Alendronate
PlaceboDRUG

1 pill per week

Placebo

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Postmenopausal women or men \> 60 years
  • DXA T-Score at lumbar spine, total hip or femur neck \<-2,0 before the start of the bisphosphonate therapy or at baseline or at least one low trauma vertebral fracture grade 2-3 or multiple low trauma vertebral fractures independent of bone mineral densitiy
  • Pretreatment with bisphosphonates for at least four years
  • Risk for hip and vertebral fractures min. 30% according to DVO-guideline for osteoporosis 2009
  • Signed informed consent

You may not qualify if:

  • Other pharmacological treatment of osteoporosis during the last 48 months
  • Other bone diseases
  • Malabsorption syndromes
  • Renal insufficiency with a calculated creatinine clearance \< 35 ml/min
  • Diseases of the esophagus, delayed esophageal clearance
  • UUnability to realise the intake instructions
  • Hypocalcemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Internal Medicine III, Alfried Krupp Krankenhaus Essen Steele

Essen, 45276, Germany

Location

MeSH Terms

Conditions

OsteoporosisOsteoporotic Fractures

Interventions

Alendronate

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesFractures, BoneWounds and Injuries

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic Chemicals

Limitations and Caveats

Due to a low recruitment rate, the study was early terminated.

Results Point of Contact

Title
Johannes Pfeilschifter, MD
Organization
Ruhr-Universität Bochum
Johannes.Pfeilschifter@rub.de

Study Officials

  • Johannes Pfeilschifter, Prof. Dr. med.

    Alfried Krupp Krankenhaus Essen Steele

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department of Internal Medicine III

Study Record Dates

First Submitted

January 11, 2012

First Posted

January 19, 2012

Study Start

February 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

February 12, 2019

Results First Posted

January 17, 2019

Record last verified: 2019-01

Locations

DE(1)