An Exploratory Randomized comparative clinical trial for the preventive effect of Denosumab versus Zoledronic acid against bone loss around femoral implants after total hip arthroplasty

An Exploratory Randomized comparative clinical trial for the preventive effect of Denosumab versus Zoledronic acid against bone loss around femoral implants after total hip arthroplasty - An Exploratory Randomized comparative clinical trial for the preventive effect of Denosumab versus Zoledronic acid against bone loss around femoral implants after total hip arthroplasty

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000030571

Enrollment

Registered

2017-12-26

Start date

2018-01-10

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with hip osteoarthritis or osteonecrosis who are undergoing total hip arthroplasty.

Interventions

Denosumab is administered by injection along with Eldecalcitol biannually. Zoledronic acid is administered by injection along with Eldecalcitol once a year.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Patients diagnosed with hip osteoarthritis or necrosis and are undergoing total hip arthroplasty for the first time; 2)Patients who are using SL-PLUS MIA HA stem (Smith & Nephew) for their implants; 3)Patients who have been diagnosed with osteoporosis; 4)Men aged 20 to 79 or women aged 50 to 79 who had the last menstruation over a year ago at the time of informed consent; 5)Patients who can write the informed consent on their own.

Exclusion criteria

Exclusion criteria: 1)Patients who have taken the following drugs for the treatment of osteoporosis: a)calcium, b)female hormone, c)activated vitamin D3, d)vitamin K, e)bisphosphonate, f)SERM, g)calcitonin, h)parathyroid hormone, PTH, i)Anti-RANKL antibody, j)Ipriflavone and k)Anabolic hormone 2)Patients diagnosed with rheumatoid arthritis; 3)Patients diagnosed with diabetes (HbA1c>7.6) within 14 days of pre-registration; 4)Patients who has/had suffered from urinary tract stones; 5)Patients who are having tooth extraction or an implant at the time of registration or during a study period; 6)Patients with liver dysfunction (GOT>36IU/L, GPT>36IU/L) within 14 days of pre-registration; 7)Patients with urinary dysfunction (creatinine clearance<35ml/min) within 14 days of pre-registration; 8)Patients with serum calcium level of less than 9.0 or more than of 10.2; 9)Patients with paralysis or a brain degenerative disease; 10)Patients with systemic infection; 11)Patients who cannot take medicine orally; 12)Patients with gastrointestinal disorder that might inhibit the absorption of medicines; 13)patients who are disqualified as sample for this research by principal and co-investigator.

Design outcomes

Primary

Measure	Time frame
Changes in bone mineral density around the femoral implants in 1 year after total hip arthroplasty.	—

Countries

Japan

Contacts

Public ContactTaro Tezuka

Yokohama City University Department of Orthopaedic Surgery

tettu59@hotmail.com+81457872655

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026