Skip to content

The efficacy and safety of technetium [99Tc] methylene bisphosphonate in the treatment of rheumatoid immune disease with osteoporosis or low bone mass: An open-label, single-arm, single-center clinical trial

The efficacy and safety of technetium [99Tc] methylene bisphosphonate in the treatment of rheumatoid immune disease with osteoporosis or low bone mass: An open-label, single-arm, single-center clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052383
Enrollment
Unknown
Registered
2021-10-24
Start date
2022-01-01
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

rheumatoid immune disease with osteoporosis or low bone mass

Interventions

99Tc-MDP Group:99Tc-MDP

Sponsors

Leshan People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Subjects must provide informed consent and voluntarily sign the informed consent form prior to any research procedure; 2. The age of the subjects is greater than or equal to 18 years old; 3. A definite diagnosis of rheumatic immune disease, the type of disease is not limited but should be consistent with the diagnosis of rheumatic immune disease; 4. There is no limit to the duration of the included patients; 5. The peak bone loss of subjects detected by dual energy X-ray absorptiometry is less than -1.0 standard deviation; 6. Subjects with normal or good liver and kidney function (ALT<2ULN; normal creatinine); 7. The subjects had stable routine medication within 4 weeks before administration, and had no other serious comorbidities (tumor); 8. During the study, the patient is willing and able to follow the study protocol and has high compliance.

Exclusion criteria

Exclusion criteria: 1. Intravenous bisphosphonates have been used within 3 months before administration; 2.WBC<4x10^9/L or PLT<100x10^9/L; 3. Hypertension patients with cardiac insufficiency or difficult to control with conventional drugs; 4. Have a history of allergy to bisphosphonates; 5. Epilepsy and other nervous system disorders; 6. Pregnant and lactating women.

Design outcomes

Primary

MeasureTime frame
Total procollagen type I amino-terminal propeptide;ß-collagen specific sequence;N-terminal-osteocalcin;

Secondary

MeasureTime frame
pain;Rheumatoid Arthritis Disease Activity;patient health assessment;Bath Ankylosing Spondylitis Disease Activity Index;Ankylosing Spondylitis Functional Index;Knee function score;Overall patient evaluation;Doctor's overall rating;

Countries

China

Contacts

Public ContactWang Yan

Leshan People's Hospital

1905996882@qq.com+86 18990651211

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026