Bone Histomorphometry in Postmenopausal Men and Women With Osteoarthritis Undergoing Total Hip Replacement

Osteoporosis Clinical Trial

Official title:

Bone Histomorphometry of the Proximal Femur in Denosumab-treated Subjects Undergoing Total Hip Replacement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02576652
• Other study ID #: 20140259
• Status: Completed
• Phase: Phase 4
• Start date: December 22, 2015
• Est. completion date: December 18, 2017

Study information

• Verified date: April 2019
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to determine the incidence of modeling-based bone formation in the femoral neck in participants who have received denosumab and are undergoing total hip replacement (THR).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: December 18, 2017
• Est. primary completion date: December 18, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 100 Years

Eligibility

Inclusion Criteria:

• Subject has provided informed consent/assent prior to initiation of any study-specific activities/procedures

• Ambulatory postmenopausal women and men with osteoporosis

• Scheduled to undergo elective THR due to osteoarthritis of the hip

• Received at least 2 doses of denosumab 60 mg subcutaneously over 18 months

• Last dose of denosumab within 6 months of scheduled THR

Exclusion Criteria:

• Received treatment for osteoporosis other than denosumab in one year prior to THR

• Subjects with current diagnosis of any of the following conditions are excluded

• Current, uncontrolled hypo- or hyperthyroidism (subjects who have controlled hypo- or hyperthyroidism may be eligible, provided that they have been on a stable therapy for at least 3 months [per subject report])

• Current, hypo- or hyperparathyroidism

• Osteomalacia

• Paget's disease of bone

• Other bone diseases which affect bone metabolism (eg, osteopetrosis, osteogenesis imperfecta)

• Severe chronic kidney disease (CKD), defined as CKD stage 4 or greater

• Malignancy within the last 5 years (except cervical carcinoma in situ or basal cell carcinoma)

• Self-reported alcohol or drug abuse within the previous 12 months

• Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s)

• Other investigational procedures while participating in this study are excluded

• Subject has known sensitivity to any of the products to be administered (eg, tetracycline, demeclocycline) during study

• Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and investigator's knowledge

• History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Other:
• Tetracycline
Treatment during cycle 1 consists of a total oral dose of 1000 mg of tetracycline daily for a total of 3 days.
• Demeclocycline
Treatment during cycle 2 consists of a total oral dose of 600 mg of demeclocycline daily for 3 days.

Procedure:
• Total Hip Replacement
Participants entering this study were prescheduled to undergo elective THR due to osteoarthritis. Surgery was to be performed according to local standard of care. During THR a fragment of femoral bone was acquired for histomorphometry evaluation.

Locations

Country	Name	City	State
United States	Helen Hayes Hospital	West Haverstraw	New York
United States	Research Site	West Haverstraw	New York

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Modeling Based Bone Formation in the Femoral Neck	Femoral neck bone samples were prepared according to standard procedures for bone histology and bone histomorphometry at a central bone histomorphometry facility.; Modeling based formation units in active bone-forming, tetracycline-labeled surfaces were identified by a smooth cement line.; The percentage of participants with fluorochrome labeling present in the cancellous or periosteal, or endocortical surfaces of the femoral neck indicative of modeling-based bone formation is reported.	Days 22-58 (at the time of hip replacement surgery)
Secondary	Modeling Based Formation Units in the Femoral Neck	Femoral neck bone samples were prepared according to standard procedures for bone histology and bone histomorphometry at a central bone histomorphometry facility.; Modeling based formation units in active bone-forming, tetracycline-labeled surfaces were identified by a smooth cement line. The number of modeling based formation units was evaluated at the cancellous, periosteal, and endocortical regions and is reported in units per mm of bone surface.	Days 22-58 (at the time of hip replacement surgery)
Secondary	Overfilled Remodeling-based Formation Units in the Femoral Neck	Femoral neck bone samples were prepared according to standard procedures for bone histology and bone histomorphometry at a central bone histomorphometry facility.; Remodeling-based formation units in active bone-forming, tetracycline-labeled surfaces were identified by a scalloped cement line. The number of overfilled remodeling-based formation units was evaluated at the cancellous, periosteal, and endocortical regions and is reported as units per mm of bone surface.	Days 22-58 (at the time of hip replacement surgery)
Secondary	Remodeling-based Formation Units Including Overfilled Units in the Femoral Neck	Femoral neck bone samples were prepared according to standard procedures for bone histology and bone histomorphometry at a central bone histomorphometry facility.; Remodeling based formation units in active bone-forming, tetracycline-labeled surfaces were identified by a scalloped cement line. The number of remodeling based formation units including overfilled units was evaluated at the cancellous, periosteal, and endocortical regions and is reported in units per mm of bone surface.	Days 22-58 (at the time of hip replacement surgery)

External Links

•   AmgenTrials clinical trials website