Targeting mTOR with everolimus and/or physical training for preventing postmenopausal bone loss and accelerated skeletal aging. The RapaLoad study.

Conditions

Healthy

Brief summary

- Percentage change in circulating levels of bone formation marker N-terminal fragment of procollagen type 1 (P1NP) at 24 weeks as compared with baseline.

Detailed description

- Change in circulating levels of bone turnover markers: 1)Bone resorption markers (C-terminal telopeptide of type 1 collagen (CTX) and Tartrate resistant acid phosphatase (TRAcP)) at baseline, 4, 12 and 24 weeks. 2) Bone formation markers (osteocalcin, and bone alkaline phosphatase) at baseline, 4, 12 and 24 weeks and P1NP at 4 and 12weeks, - Lumbar spine (L1-4), and total hip and femoral neck bone mineral density (BMD) meas-ured by dual-energy X-ray absorptiometry (DXA) at baseline and 24 weeks, - Bone microarchitecture, mass, and geometry at the distal radius and tibia assessed us-ing high-resolution peripheral quantitative computed tomography (HR-pQCT) at base-line and 24 weeks, - Muscle function and postural balances tested at base-line and 24 weeks, - Cardiopulmonary health estimated by measuring Vo2max at baseline and week 24., - Metabolic health: weight, body composition by DXA scanning, fasting blood glucose, fasting insulin, lipid parameters and metabolomic studies at baseline and week 24.

Related papers

No related papers found yet.

Interventions

DRUGEVEROLIMUS

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
- Percentage change in circulating levels of bone formation marker N-terminal fragment of procollagen type 1 (P1NP) at 24 weeks as compared with baseline.	—

Secondary

Measure	Time frame
- Change in circulating levels of bone turnover markers: 1)Bone resorption markers (C-terminal telopeptide of type 1 collagen (CTX) and Tartrate resistant acid phosphatase (TRAcP)) at baseline, 4, 12 and 24 weeks. 2) Bone formation markers (osteocalcin, and bone alkaline phosphatase) at baseline, 4, 12 and 24 weeks and P1NP at 4 and 12weeks, - Lumbar spine (L1-4), and total hip and femoral neck bone mineral density (BMD) meas-ured by dual-energy X-ray absorptiometry (DXA) at baseline and 24 weeks, - Bone microarchitecture, mass, and geometry at the distal radius and tibia assessed us-ing high-resolution peripheral quantitative computed tomography (HR-pQCT) at base-line and 24 weeks, - Muscle function and postural balances tested at base-line and 24 weeks, - Cardiopulmonary health estimated by measuring Vo2max at baseline and week 24., - Metabolic health: weight, body composition by DXA scanning, fasting blood glucose, fasting insulin, lipid parameters and metabolomic studies at baselin	—

Measure

Time frame

- Change in circulating levels of bone turnover markers: 1)Bone resorption markers (C-terminal telopeptide of type 1 collagen (CTX) and Tartrate resistant acid phosphatase (TRAcP)) at baseline, 4, 12 and 24 weeks. 2) Bone formation markers (osteocalcin, and bone alkaline phosphatase) at baseline, 4, 12 and 24 weeks and P1NP at 4 and 12weeks, - Lumbar spine (L1-4), and total hip and femoral neck bone mineral density (BMD) meas-ured by dual-energy X-ray absorptiometry (DXA) at baseline and 24 weeks, - Bone microarchitecture, mass, and geometry at the distal radius and tibia assessed us-ing high-resolution peripheral quantitative computed tomography (HR-pQCT) at base-line and 24 weeks, - Muscle function and postural balances tested at base-line and 24 weeks, - Cardiopulmonary health estimated by measuring Vo2max at baseline and week 24., - Metabolic health: weight, body composition by DXA scanning, fasting blood glucose, fasting insulin, lipid parameters and metabolomic studies at baselin

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Countries

Denmark

Outcome results

None listed