AuthorisedTherapeutic use (Phase IV)Interventional

Active vitamin D for secondary hyperparathyroidism after bariatric surgery: a multicenter randomized controlled trial (ActiVitD)

This research, called ActiVitD, is investigating a common health problem after weight-loss surgery, known as secondary hyperparathyroidism. This condition involves the parathyroid glands making too much parathyroid hormone (PTH), even when vitamin D levels are good. The study is a Phase IV trial, meaning it's testing a medicine that is already approved. Researchers want to see if different doses of a vitamin D medicine called Etalpha can help normalise PTH levels over two years. They will also be checking how this treatment affects bone strength and overall quality of life for the participants. Anyone aged 18 or over, regardless of gender, who has this condition may be eligible to take part.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Academisch Ziekenhuis Leiden

Enrolment target

130

Start

04 Nov 2024

Secondary hyperparathyroidism

What is this study about?

This study, called ActiVitD, is looking at a condition called secondary hyperparathyroidism. This can sometimes happen after weight-loss surgery. Essentially, it means that the small glands in your neck, called parathyroid glands, are working overtime and producing too much of a hormone called PTH. Even if your general vitamin D levels are good, this can still be a problem. The researchers want to understand if a specific type of vitamin D medicine, called Etalpha, can help bring these PTH levels back to normal.

The study is designed to see if this medicine can help restore a healthy balance over a period of two years. They are using different doses of Etalpha – 0.25 microgram, 0.5 microgram, and 1 microgram capsules – to find out which approach works best. The main thing they're tracking is whether PTH levels become normal again for people in the study.

Besides tracking PTH levels, the researchers are also interested in other aspects of health. They'll be checking participants' bone density (how strong their bones are) and their quality of life. This means how they feel generally, using a special questionnaire. This will help them understand the full impact of the treatment on people's lives.

Key takeaways

This study evaluates Etalpha, a vitamin D medicine, for high PTH levels after weight-loss surgery.
The main goal is to normalise PTH levels over two years.
It also checks effects on bone strength and quality of life.
Participants will receive one of three active doses of Etalpha.
Regular clinic visits, blood tests, and bone scans are part of participation.
The study lasts for two years.

Who may be eligible?

To be part of this study, you need to meet certain criteria. First, you must be at least 18 years old – there's no upper age limit. The study welcomes both men and women.

The most important health requirement is that you have secondary hyperparathyroidism, which developed after you had weight-loss surgery. This means your parathyroid hormone (PTH) levels are high or at the very top of the normal range, and your blood calcium levels are normal or a bit low. Also, your general vitamin D levels (25(OH)D) need to be above 50 nmol/L.

If you meet these general conditions, you might be a good candidate for this research. The study team will review your medical history and test results to confirm if you are suitable.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you had weight-loss (bariatric) surgery?
Have you been diagnosed with secondary hyperparathyroidism after your surgery?
Are your parathyroid hormone (PTH) levels high or at the upper limit of normal?
Are your blood calcium levels normal or a bit low?
Are your regular vitamin D levels (25(OH)D) above 50 nmol/L?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be assigned to one of several treatment groups, each receiving a different dose of the vitamin D medicine, Etalpha, in soft capsules. You'll take this medicine regularly as directed. Over the two-year study period, you will have regular visits to the clinic for follow-up appointments. These appointments will involve blood tests to check your PTH levels, calcium, and other important markers to track how well the treatment is working.

The study will also involve scans to measure your bone density – how strong your bones are – at the start, at one year, and again at two years. You'll also be asked to complete questionnaires about your quality of life every six months using a tool called OBESI-Q. The total duration of your active participation, including all follow-up, will be two years.

Potential risks and benefits

Taking part in this study might offer potential benefits, such as receiving treatment that could help normalise your PTH levels and improve your bone health. You would also be closely monitored by medical professionals. As with any medication, there are potential risks and side effects associated with Etalpha. Your study doctor will explain these to you in detail. It’s important to remember that you are in control; you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands

Common questions

What is secondary hyperparathyroidism?

It's a condition where your parathyroid glands make too much parathyroid hormone (PTH), often related to weight-loss surgery and possibly affecting your bone health.

What is Etalpha?

Etalpha is a type of vitamin D medicine that is being tested in this study to see if it can help control PTH levels.

What's a 'Phase IV' study?

This means the medicine being tested is already approved, and researchers are gathering more information about its use in specific patient groups like those after weight-loss surgery.

How long will I be involved in the study?

If you join, the study will last for two years, with regular check-ups and assessments during that time.

Will I know if I'm getting medicine or a dummy pill?

This study uses different doses of the active medicine (Etalpha), so all participants will receive one of the active doses. There isn't a dummy pill (placebo) group in this specific trial.