Therapy of the Skeletal Disease of Type 2 Diabetes With Denosumab

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2, Osteoporosis

In brief

The goal of the study is to characterize the effect of Prolia® (denosumab) on indices of bone strength in type 2 diabetes (T2D). The investigational plan involves administration of Prolia® or identical placebo for 12 months as a randomized double-blind placebo-controlled trial in 66 T2D postmenopausal women assigned to Prolia® or placebo. The study will include assessment of different measures of bone quality: skeletal microarchitecture, including measurement of skeletal cortical pores; bone mineral density; bone material quality, and accumulation of advanced glycation endproducts (AGEs) in collagen. This information will help to determine whether Prolia® treatment in type 2 diabetes has skeletal benefits.

Key facts

Study ID

NCT03457818

Run by

Mishaela Rubin

People needed

8

Starts

2018-11-07

Expected to finish

2020-06-10

Last updated by the study team

2024-07-03

Who can join

Age: 50 and older, up to 90. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• An understanding, ability and willingness to fully comply with study procedures and restrictions.
• Ability to voluntarily provide written, signed and dated informed consent as applicable to participate in the study.
• Postmenopausal women age ≥ 50 and ≤ 90 years at time of consent.
• Diagnosis of T2D for ≥ 2 years. Upon review of patient's medical history, patient will be confirmed to currently have reasonably controlled T2D as assessed by the investigator, with HbA1c ≤ 8.4%. If HbA1c is ≥ 8.5%, re-screening will be allowed after approximately 3 months following adjustment of diabetes therapy.
• DXA T-score ≤ -1.0 at one or more sites (lumbar spine, femoral neck, total hip or distal 1/3 radius).
• Normal albumin-adjusted serum calcium level.

You may not qualify if…

• Hormone replacement treatment 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 renal disease stage 4 or worse, chronic liver disease, malignancy, hypoparathyroidism or hyperparathyroidism, acromegaly, Cushing's syndrome, hypopituitarism, chronic obstructive pulmonary disease, alcohol intake > 3 units/day).
• Treatment with any of the following drugs in past year: anticonvulsant therapy, pharmacological doses of thyroid hormone (TSH<normal is permitted if subject has normal T4, clinical euthyroidism and is in steady-state), adrenal or anabolic steroids, calcitonin, estrogen or selective estrogen receptor modulator, sodium fluoride (other than dental treatment), teriparatide, denosumab, abaloparatide, strontium or aromatase inhibitors; any history of bisphosphonate treatment. Corticosteroid use permitted if subject is in steady-state.
• 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.
• Clinically significant hypersensitivity to denosumab or any components of denosumab 60 mg.
• Known sensitivity to any of the products to be administered during the study (e.g., calcium or vitamin D).
• Subject is pregnant or breast feeding, or planning to become pregnant within 5 months after the end of treatment.
• Female subject of child bearing potential and is not willing to use, in combination with her partner, highly effective contraception during treatment and for 5 months after the end of treatment.
• Significant dental/oral disease, including prior history or current evidence of osteonecrosis/osteomyelitis of the jaw, or the following:
• Active dental or jaw condition which requires oral surgery
• Non-healed dental/oral surgery
• Planned invasive dental procedures for the course of the study
• DXA T-score of ≤ -3.5 at any site.

Where it is running

• Columbia University Irving Medical Center - Harkness Pavillion — New York, New York, United States

Full record on ClinicalTrials.gov

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