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Effects of metformin and alendronate on reducing bone loss and improving glucose metabolism in diabetic patients with osteoporosis

Effects of metformin and alendronate on reducing bone loss and improving glucose metabolism in diabetic patients with osteoporosis

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400093485
Enrollment
Unknown
Registered
2024-12-05
Start date
2024-05-07
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

Osteoporosis

Interventions

Treatment group 1:Oral alendronate (70 mg) weekly with glucose-lowering agents other than metformin
All participants received daily supplementation of calcium (1000 mg) and vitamin D (at least 400 IU).
Treatment group 2:Oral alendronate (70 mg) weekly with metformin (2 g/d in divided doses).All participants received daily supplementation of calcium (1000 mg) and vitamin D (at least 400 IU).
Treatment group 3:Oral alendronate (70 mg) once weekly. All participants received daily supplementation of 1000 mg calcium and at least 400 international units of vitamin D.
Treatment group 4:Oral metformin only (2 g daily, divided into two doses). All participants received daily supplementation of 1000 mg calcium and at least 400 international units of vitamin D.

Sponsors

The Affiliated Taizhou People's Hospital of Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age greater than 40 years;2.BMD t score of<=-2.5 for the lumbar spine, total hip, or femoral neck, or a BMD t score of <=-1.0 for any of these sites, and a history of one or more fragility fractures of the vertebral, hip, proximal humerus, or distal radius;3.Diagnosed with T2DM according to guidelines of the American Diabetes Association (ADA).

Exclusion criteria

Exclusion criteria: 1. There are contraindications for the use of alendronate or metformin; 2. Hereditary bone disease or secondary osteoporosis; 3. A history of malignant tumors or radiation therapy; 4. Severe heart, lung, liver, or kidney disease; 5. Severe mental illness or cognitive impairment.

Design outcomes

Primary

MeasureTime frame
Bone Mineral Density;Fasting Blood Glucose;

Secondary

MeasureTime frame
Homeostasis Model Assessment of Insulin Resistance;C-terminal telopeptide of type I collagen ;Procollagen Type I N-terminal Propeptide;

Countries

China

Contacts

Public ContactHongyang Kong

The Affiliated Taizhou People's Hospital of Nanjing Medical University

konghongyang2024@163.com+86 183 6001 4487

Outcome results

None listed

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