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The preventive effect of medicine for osteoporosis on osteopenia in patients with Parkinson's disease: multicenter/ non-blind/ randomised/ exploratory clinical trial

The preventive effect of medicine for osteoporosis on osteopenia in patients with Parkinson's disease: multicenter/ non-blind/ randomised/ exploratory clinical trial - The preventive effect of medicine for osteoporosis on osteopenia in patients with Parkinson's disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000033285
Enrollment
100
Registered
2018-07-05
Start date
2018-08-01
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

Parkinson&#39

Interventions

Oral bisphosphonate agent group: taking orally Minodronic Acid Hydrate (50mg) 1 tablet per 4 weeks Intravenous bisphosphonate agent group: injecting Zoledronic Acid (5mg) 1 ampule per 48 weeks

Sponsors

Department of Orthopaedic Surgery, Niigata University Medical and Dental Hospital
Lead Sponsor
Department of Neurology, Nishi-Niigata Chuo Hospital
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.50 years or more of age at the time of the consent 2.Patient with Parkinson's disease diagnosed by a professional neurologist 3.patient with primary osteoporosis as in the following case; ?histroy of any types of fragile fracture ?<80% of young adult mean in dual-energy x-ray absorptiometry 4.untreated patient with bone antiresorptive agent or bone anabolic agent 5.patient obtaining the consent based on the patient's free will 6.patient taking anti-Parkinson's disease agent without dysphasia

Exclusion criteria

Exclusion criteria: 1.patient corresponding to contraindication based on the attached document of the bone antiresorptive agents 2.patient with Hoen-Yahr grade 5 Parkinson's disease 3.patient who is considered not to be suited for this survey

Design outcomes

Primary

MeasureTime frame
Primary evaluation item: change of the mean BMD in the prximal femur 2 years after initial treatment secondary evaluation item: 1.Change of the mean BMD in the proximal femur or lumbar spine 2 years after initial tramentt 2.Change of the bone absorption marker 3.Prevalence of new-onset fragile fracture 4.Correlation between QOL and spinal alignment 5.Longitudinal evaluation of BMD or bone resorption marker Safty assessment: Incidecne of adverse reactions for follow-up period

Countries

Japan

Contacts

Public ContactKei Watanabe

Niigata University Medical and Dental Hospital Orthopaedic Surgery

keiwatanabe_39jp@live.jp025-227-2272

Outcome results

None listed

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