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

Amgen

Status and phase: Completed; Phase 4

Conditions: Osteoporosis

Treatments: Other: Demeclocycline; Other: Tetracycline; Procedure: Total Hip Replacement

Study type: Interventional

Funder types: Industry

Identifiers

NCT02576652

20140259

Details and patient eligibility

About

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).

Enrollment: 6 patients

Sex: All

Ages: 50 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Osteoarthritis Participants

Other group

Description:

Participants previously treated with denosumab and planning to undergo total hip replacement (THR) received one cycle of tetracycline administered at either 250 mg four times a day or 500 mg twice a day for 3 days and one cycle of demeclocycline administered at either 150 mg four times a day or 300 mg twice a day for 3 days, ten days after last dose of tetracycline in cycle 1. THR surgery was performed 5 to 42 days after the last dose of demeclocycline.

Treatment:

Other: Demeclocycline

Procedure: Total Hip Replacement

Other: Tetracycline