Status:
COMPLETED
Advanced Glycation Endproducts and Bone Material Strength in T2D Treated With Pyridoxamine
Lead Sponsor:
Columbia University
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
FEMALE
65+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine if a specific form of Vitamin B known as Pyridoxamine helps improve bone strength over one year in women (\>65 yrs old) with Type 2 Diabetes. The investigator...
Detailed Description
Type 2 Diabetes Mellitus (T2DM) has become one of the most important diseases of our time. Recent research shows that diabetes has negative effects on bones and that people with diabetes might more li...
Eligibility Criteria
Inclusion
- Postmenopausal women ≥65 years
- Diagnosis of T2D for ≥ 5 years, with all HbA1c levels.
Exclusion
- Hormone replacement treatment (HTR) use (to avoid the influence of estrogen).
- Fractures (excluding skull, facial bones, metacarpals, fingers, toes, and fractures associated with severe trauma) within 12 months.
- A history of pathological fractures (eg, due to Paget's disease, myeloma, metastatic malignancy).
- Type 1 diabetes
- Disorders associated with altered skeletal structure or function (chronic liver disease' chronic renal disease stage 4 \[eGFR \< 30 mL/mim/1.73 m2\] or worse, malignancy, hypoparathyroidism or hyperparathyroidism,acromegaly, Cushing's syndrome, hypopituitarism, alcohol intake \> 3U/day).
- Treatment with any of the following drugs in part year:current corticosteroid, anticonvulsant therapy(phenytoin, phenobarbital, primidone, carbamazepine), SGLT2 inhibitor if on it for \< 1 year), pharmacological doses of thyroid hormone (TSH\<normal), adrenal or anabolic steroids, Aromatase inhibitors, calcitonin, bisphosphonates, denosumab, estrogen, or selective estrogen receptor modulator, sodium fluoride, teriparatide, thiazolidinediones(TZDs).
- Serum 25(OH)D levels \< 20 ng/ml. If 25(OH)D levels are \< 20 ng/ml, rescreening will be allowed following a vitamin D loading regimen of 50,000 IU/week for 4 weeks. If serum 25(OH) D levels are ≥ 20 ng/ml after supplementation, the subject will be allowed to enroll.
- Current use of pyridoxamine (although not multivitamin or vitamin B6 users because pyridoxamine is not at pharmacologic levels in these supplements).
- Allergy to pyridoxamine and vitamin B6.
Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2022
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT03778580
Start Date
March 1 2018
End Date
February 28 2022
Last Update
August 3 2022
Active Locations (1)
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1
Columbia University Medical Center - Harkness Pavillion
New York, New York, United States, 10032