parallel randomized trial

NCT04702516

The Effect of Semaglutide (Ozempic) on Bone Turnover in Patients With Increased Fracture Risk: a Randomized Placebo-controlled Clinical Trial

Design

Randomized: 64
Start year: 2021
Treatment: 52 weeks, follow-up 58 weeks
Countries: Denmark (2 sites)
Sponsor: Odense University Hospital (mixed)
Eligibility: age 40 to 85; T-score below -1.0 at hip or spine or recent low energy fracture; no diabetes; BMI 20 or more

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Semaglutide 1.0 mg subcutaneous once weekly Semaglutide 1.0 mg once weekly	calcium at least 800 mg and vitamin D 20 ug daily; lifestyle: none	32	32
A2	Placebo Placebo	calcium at least 800 mg and vitamin D 20 ug daily; lifestyle: none	32	32

As printed in the trial reports or registry, per arm or for the whole trial.

Characteristic	Statistic	Semaglutide 1.0 mg subcutaneous once weekly A1	Placebo A2
age	mean (years)	62.7	63.6
age	sd (years)	5.6	5.4
black	n	1	0
black	percent	3
bmi	mean (kg/m2)	27.9	27.6
bmi	sd (kg/m2)	4.8	4.3
female	n	28	27
female	percent	87	84
hba1c	mean (percent)	6.19	6.25
hba1c	sd (percent)	0.4	0.5
other osteoporosis	n	9	6
other osteoporosis	percent	28	19
weight	mean (kg)	77.4	76.7
weight	sd (kg)	14.5	13.2
white	n	31	32
white	percent	97	100

12 adjudicated result lines, grouped by outcome. Open an outcome to see its values.

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 32	not stated; safety; R0011399:Table 3
	A2	events				2 / 32	not stated; safety; R0011399:Table 3

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				13 / 32	not stated; safety; R0011399:Table 3
	A2	events				1 / 32	not stated; safety; R0011399:Table 3

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 32	not stated; safety; R0011399:Table 3
	A2	events				0 / 32	not stated; safety; R0011399:Table 3

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 32	not stated; safety; R0011399:Table 3
	A2	events				0 / 32	not stated; safety; R0011399:Table 3

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				7 / 32	not stated; safety; R0011399:Table 3
	A2	events				1 / 32	not stated; safety; R0011399:Table 3

Gallbladder and biliary disease (2 lines; O28)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 32	not stated; safety; gallstones; R0011399:Table 3
	A2	events				1 / 32	not stated; safety; gallstones; R0011399:Table 3