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Senolytics to Improve Osteoporosis Therapy

Plain-language guide to NCT06018467: phase 2 randomized trial of NAD+, osteoporosis and bone density, 120 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06018467
Phase
phase 2
Status
active, not recruiting
Start
2023-09-06
Completion (planned or actual)
2026-04-30
Participants
120 (estimated)
Design
randomized, single-blind, treatment
Conditions studied
Osteopenia, Osteoporosis; Age-related Bone Loss
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 2 trial tested NAD+ for osteoporosis and bone density.

This randomised clinical trial aims to study osteoporosis as a disease of accelerated skeletal aging caused by the accumulation of senescent cells within the skeleton and investigate the effects and safety of senolytics and antioxidant therapy on bone.

It had three arms (groups): Dasatinib plus Quercetin (DQ) (experimental), Nicotinamide Riboside (NR) (experimental) and Control (no intervention).

The participants in the Control group, will not receive any treatment for 20 weeks.

The registry classes the interventions as dietary supplement and drug.

More on the Plan

The aim of this randomised clinical trial is to study osteoporosis as a disease of accelerated skeletal aging caused by accumulation of senescent cells within the skeleton and investigate the effects and safety of senolytics and antioxidant therapy on bone.

The main trial endpoint is the percent change in circulating marker of bone resorption (CTX) measured at baseline and at week 21.

Secondary endpoints are the changes in bone resorption marker tartrate resistant acid phosphatase (TRAcP) and bone formation markers (PINP, osteocalcin, and bone alkaline phosphatase) measured at baseline and at 21 weeks.

Trial design: The study design is a randomised controlled open-label clinical trial.

Who Took Part

120 planned participants were the target.

It was open to people of any sex aged from 60 years up to 90 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Ability to provide informed consent.

The full record lists 4 inclusion and 21 exclusion criteria; among the exclusions: DXA of hip or spine not possible e.g., due to a prosthesis; inability to provide fasting blood samples; primary hyperparathyroidism.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

Because people in this NAD+ study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the osteoporosis and bone density participants stayed in one arm throughout.

In this single-blind NAD+ study one party knew the assignments and the other did not.

Those kept unaware of assignments: outcomes assessor.

It started in 2023-09-06 with completion listed for 2026-04-30.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Bone resorption marker CTX (time frame: Baseline, week 5, week 13, week 21).

It also tracked 2 secondary outcomes, for example Bone resorption marker TRAcP and Bone formation markers (PINP, osteocalcin, and bone alkaline phosphatase).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of NAD+ in 120 people with osteoporosis and bone density.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the NAD+ compound page, Osteoporosis and bone density research.

Our Notes on the Compound

NAD+: The coenzyme that accepts electrons at complex I.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.