Bone, Exercise, Alendronate, and Caloric Restriction

ConditionBone Loss

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age60+

SponsorWake Forest University Health Sciences

About this trial

The purpose of this research is to identify strategies that minimize bone loss that occurs when older adults lose weight. Participation in this research will involve up to nine assessment visits and last up to two years.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Community-dwelling

BMI>30 kg/m² or BMI 25.0 to <30 kg/m² plus one risk factor

Currently receiving routine (annual) dental care

Pre-existing low bone mass (T-score ≤-1.1 to >-2.5 at the hip, femoral neck, or lumbar spine (L1-L4))

Disqualifiers

Weight greater than 450 lbs (DXA limit)

Resides with someone who is currently participating in BEACON

Dependent on quad cane or walker; inability to walk independently

History of mild cognitive impairment or dementia or evidence of cognitive impairment ((score <20) on Montreal Cognitive Assessment (MoCA))

Trial design

Design model

Factorial

Treatments tested in this trial

Bisphosphonate
Drug
Medicine used to treat bone problems, called osteopenia or osteoporosis.
Resistance Training/Bone-Loading Exercise
Behavioral
Exercise in small groups three days per week under the supervision of exercise physiologists. Heart rate and blood pressure will be measured before and after each session and participants will warm-up by walking or cycling for five minutes at a slow pace. All RT exercises will be conducted on machines which accommodate different body sizes and allow small increments in resistance, both important considerations for low functioning older adults with obesity.
Placebo
Other intervention
Capsules identical to the active alendronate capsules without any active ingredients with the same dosing and follow up as BIS treatment group.

Treatment groups

900 Participants

are divided into 4 treatment groups

Group A: Resistance Training (RT) + Bisphosphonate (BIS)Experimental treatment 2 interventions

Group B: No RT + BISExperimental treatment 1 intervention

Group C: No RT + Placebo (PL)Active comparator 1 intervention

Group D: RT + PLActive comparator 2 interventions

Trial outcomes

Primary outcomes

Change in total hip areal bone mineral density (aBMD)

Dual X-ray absorptiometry (DXA) derived

Time frame

from baseline through month 12

Secondary outcomes

aBMD assessment of the femoral neck

DXA derived

Time frame

baseline, month 6, month 12

aBMD assessment of the lumbar spine

DXA derived

Time frame

baseline, month 6, month 12

Tibial Trabecular (Tb) BMD

HR-pQCT acquired; Average volumetric BMD \[mg/cm3\]

Time frame

baseline and month 12

Tibial Cortical (Ct.) BMD

HR-pQCT acquired; Avg. volumetric BMD \[mg/cm3\]

Time frame

baseline, month 6, month 12

Other outcomes

Tibial Total bone mineral density (Tt.BMD)

High resolution peripheral quantitative computed tomography (HR-pQCT) acquired; Avg. volumetric BMD \[mg/cm3\]

Time frame

baseline and month 12

Tibial Total Area (Tt.Ar)

HR-pQCT acquired; Avg. cross-sectional area (all slices)

Time frame

baseline and month 12

Tibial Trabecular Area (Tb Ar)

HR-pQCT acquired; Avg. cross-sectional area (all slices)

Time frame

baseline and month 12

Tibial Cortical Area (Ct.Ar)

HR-pQCT acquired; Avg. cross-sectional area (all slices)

Time frame

baseline and month 12

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wake Forest University Health Sciences

Lead sponsor

National Institute on Aging (NIA)

Collaborator

Source ClinicalTrials.gov

Apply now