What side effects are associated with this type of intervention?

Common treatments for osteoporosis, such as bisphosphonates (e.g., alendronate, zoledronic acid) and osteoclast inhibitors (e.g., denosumab), are generally effective in increasing bone mineral density. However, they come with potential side effects. Bisphosphonates can cause gastrointestinal issues, such as nausea and esophageal irritation, and in rare cases, osteonecrosis of the jaw and atypical femoral fractures. Denosumab may lead to hypocalcemia and an increased risk of infections. Both types of medications can also cause musculoskeletal pain. Additionally, the use of these treatments in the context of increased sympathetic nervous system tone, as seen in night shift work, may exacerbate these side effects or introduce new ones related to altered bone metabolism.

What prior FDA approvals exist?

The FDA has approved several bisphosphonates for the treatment of osteoporosis, including alendronate, risedronate, and zoledronic acid. These drugs work by inhibiting osteoclast-mediated bone resorption, thereby increasing bone mineral density (BMD) and reducing fracture risk. Additionally, the FDA has approved anabolic agents like teriparatide, which stimulates bone formation. Denosumab, a monoclonal antibody that inhibits RANKL, has also been approved for osteoporosis treatment. These treatments are designed to manage bone turnover and improve bone health, which could be relevant in contexts where bone metabolism is affected by factors such as increased sympathetic nervous system tone.

What other types of research exist?

Promising alternatives for osteoporosis treatment in 2024 include evening calcium supplementation, which suppresses bone resorption, and regular exercise, which has been shown to improve bone density.

← Back to Search

Simulated Night Shift for Circadian Rhythm Disorder (SPOTLIGHT Trial)

Q: What is the mechanism of action of this treatment?

Common treatments for osteoporosis include bisphosphonates, hormone replacement therapy (HRT), denosumab, and teriparatide. Bisphosphonates inhibit osteoclast-mediated bone resorption, increasing bone mineral density (BMD). HRT helps maintain bone density by compensating for decreased hormone levels post-menopause. Denosumab inhibits RANKL, reducing osteoclast formation and bone resorption. Teriparatide stimulates osteoblast activity, promoting new bone formation. These treatments are vital for osteoporosis patients as they address the imbalance between bone resorption and formation, reducing fracture risk and improving bone health.

N/A

Recruiting

Led By Christine M Swanson, MD, Phd

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Women must be premenopausal, on continuous combination oral contraception and not breastfeeding

Healthy, nonpregnant adults 20-40 years old who habitually sleep 7-9 hours during the biological night

Must not have

Travel > 1 time zone within 4 weeks prior to the study or need to travel >1 time zone during study

Individuals with eGFR < 60 mL/min/1.73m2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to day 11

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if working night shifts affects bone health by increasing stress levels. It will also check if returning to a normal sleep schedule can reverse any negative effects.

Who is the study for?

Healthy adults aged 20-40, who sleep 7-9 hours at night and are fully vaccinated against COVID-19. Women must be premenopausal, on oral contraception, not breastfeeding. Participants should commit to a study including inpatient stays and wear a wrist monitor for activity tracking.

What is being tested?

The trial is testing how simulated night shift work affects bone metabolism by measuring bone turnover markers and sympathetic nervous system tone. It involves two sets of four-night inpatient stays with follow-up to see if normal patterns reverse any changes.

What are the potential side effects?

There may not be direct side effects from the intervention as it's a lifestyle simulation rather than medication; however, participants might experience fatigue or stress due to altered sleep patterns.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a premenopausal woman not breastfeeding and on birth control pills.

Select...

I am a healthy adult, aged 20-40, not pregnant, and I usually sleep 7-9 hours at night.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have not traveled across time zones recently and won't need to during the study.

Select...

My kidney function is reduced, with an eGFR below 60.

Select...

I haven't had any major health issues or head injuries in the past year.

Select...

I do not have symptoms like fever at the time of enrollment.

Select...

I cannot travel to the CU-AMC campus for study visits.

Select...

I have a serious sleep disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to day 11

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to day 11

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 11 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Difference in change in propeptide of type 1 procollagen (P1NP)

Secondary study objectives

Between-group differences in the change in CTX (C-telopeptide of type I collagen)

Between-group differences in the change in osteocalcin.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Simulated Night Shift WorkExperimental Treatment1 Intervention

Two inpatient stays, each involving a baseline night, followed by a 3-hour afternoon nap opportunity, and then three 12-hour night shifts, with 8-hour daytime sleep opportunity in between.

Group II: Control (8 hours nocturnal sleep)Active Control1 Intervention

Inpatient protocol involves 8-hour sleep opportunity during the biological night throughout.

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for osteoporosis include bisphosphonates, hormone replacement therapy (HRT), denosumab, and teriparatide. Bisphosphonates inhibit osteoclast-mediated bone resorption, increasing bone mineral density (BMD). HRT helps maintain bone density by compensating for decreased hormone levels post-menopause. Denosumab inhibits RANKL, reducing osteoclast formation and bone resorption. Teriparatide stimulates osteoblast activity, promoting new bone formation. These treatments are vital for osteoporosis patients as they address the imbalance between bone resorption and formation, reducing fracture risk and improving bone health.

Glucocorticoid induced osteoporosis.Melatonin-micronutrients Osteopenia Treatment Study (MOTS): a translational study assessing melatonin, strontium (citrate), vitamin D3 and vitamin K2 (MK7) on bone density, bone marker turnover and health related quality of life in postmenopausal osteopenic women following a one-year double-blind RCT and on osteoblast-osteoclast co-cultures.Effects of combined ovariectomy with dexamethasone on rat lumbar vertebrae.