Clinical trial NCT02576652: Bone Histomorphometry in Postmenopausal Men and Women With Osteoarthritis Undergoing Total Hip Replacement
Official title: Bone Histomorphometry of the Proximal Femur in Denosumab-treated Subjects Undergoing Total Hip Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoporosis
Keywords: bone biopsy
tetracycline
demeclocycline
total hip replacement
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2015-10-15
Enrollment: 6
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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).


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Modeling Based Bone Formation in the Femoral Neck
timeFrame: Days 22-58 (at the time of hip replacement surgery)
Secondary outcomes:
measure: Modeling Based Formation Units in the Femoral Neck
timeFrame: Days 22-58 (at the time of hip replacement surgery)
measure: Overfilled Remodeling-based Formation Units in the Femoral Neck
timeFrame: Days 22-58 (at the time of hip replacement surgery)
measure: Remodeling-based Formation Units Including Overfilled Units in the Femoral Neck
timeFrame: Days 22-58 (at the time of hip replacement surgery)
Other outcomes:
Locations:
city: West Haverstraw
country: United States
facility: Helen Hayes Hospital
state: New York
city: West Haverstraw
country: United States
facility: Research Site
state: New York
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Dempster DW, Chines A, Bostrom MP, Nieves JW, Zhou H, Chen L, Pannacciulli N, Wagman RB, Cosman F. Modeling-Based Bone Formation in the Human Femoral Neck in Subjects Treated With Denosumab. J Bone Miner Res. 2020 Jul;35(7):1282-1288. doi: 10.1002/jbmr.4006. Epub 2020 Apr 2.