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The efficacy and safety of treatment with zoledronic acid in patients and the influence of patient characteristics.

The efficacy and safety of treatment with zoledronic acid in patients and the influence of patient characteristics. - The efficacy and safety of treatment with zoledronic acid in patients and the influence of patient characteristics.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000042547
Enrollment
100
Registered
2020-11-25
Start date
2020-04-24
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

Primary osteoporosis

Interventions

None listed

Sponsors

Koenji Orthopedics Clinic
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Patients who met the required inclusion criteria were enrolled in this study. 1. Patients with osteoporosis starting the treatment using ZOL from November 2016 to June 2019 at Koenji Orthopedics Clinic 2. Patients 55 years of age or older 3. Postmenopausal women who were diagnosed with primary osteoporosis

Exclusion criteria

Exclusion criteria: 1. Patients with a metabolic bone disease other than osteoporosis 2. Patients with a history of hypersensitivity to the study drug or BP 3. Patients who have severe renal impairment (creatinine clearance < 35 mL/min) at the start 4. Patients who are dehydrated (high fever, severe diarrhea and vomiting, etc.) at the start 5. Patients who have hypocalcemia at the start 6. Patients whom the physicians judged to be unsuitable because of idiosyncratic complications and markedly different background

Design outcomes

Primary

MeasureTime frame
The rate of change in the lumbar spine BMD.

Secondary

MeasureTime frame
The rate of change in the femoral neck BMD, the changes in type I procollagen N-terminal propeptide (P1NP), tartrate-resistant acid phosphatase-5b (TRACP-5b), VAS score of back pain, Japanese Osteoporosis Quality of Life Questionnaire (JOQOL).

Countries

Japan

Contacts

Public ContactFumitoshi Omura

Koenji Orthopedics Clinic N/A

oomura-f@rg7.so-net.ne.jp03-5377-3291

Outcome results

None listed

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